A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01557244
Collaborator
(none)
181
84
5
91.4
2.2
0
Study Details
Study Description
Brief Summary
The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
181 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)
Actual Study Start Date
:
Jul 2, 2012
Actual Primary Completion Date
:
Nov 7, 2019
Actual Study Completion Date
:
Feb 13, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fesoterodine PR 4 mg Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period |
Drug: Fesoterodine PR 4 mg
Fesoterodine 4 mg tablet once daily for 24 weeks
|
| Experimental: Fesoterodine PR 8 mg Fesoterodine 8 mg for first week followed by 11 weeks at 8 mg in active control period, followed by 12 weeks in safety extension period. |
Drug: Fesoterodine PR 8 mg
Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
Drug: Fesoterodine PR 8 mg
Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
|
| Active Comparator: Oxybutynin Oxybutynin |
Drug: Oxybutynin
Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation.
Drug: Fesoterodine PR
Fesoterodine 4 mg or 8 mg tablets once daily for 12 weeks after 12 weeks of oxybutinin. Those assigned to 8 mg will take 4 mg for the first week.
Other Names:
|
| Experimental: Fesoterodine BIC 2 mg Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period. |
Drug: Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
|
| Experimental: Fesoterodine BIC 4 mg Fesoterodine BIC 4 mg for first week followed by 11 weeks at 8 mg in the efficacy period, followed by 12 weeks in safety extension period. |
Drug: Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O).
Secondary Outcome Measures
- Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing.
- Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
In this outcome measure, shift data have been reported using 4 categories: (1) number of participants who did not have IDC at Baseline and at Week 12, (2) number of participants who did not have IDC at Baseline but had IDC at Week 12, (3) number of participants who had IDC at Baseline but no IDC at Week 12, and (4) number of participants who had IDC at Baseline and at Week 12.
- Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
Bladder volume (in milliliter) at first IDC was measured using urodynamic testing.
- Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated).
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with >0 micturitions at Baseline.
- Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 catheterizations at Baseline.
- Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The mean number of micturitions or catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hrs) period. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.
- Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 incontinence episodes at Baseline.
- Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for participants with >0 urgency episodes at Baseline.
- Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0.
- Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume greater than 0.
- Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume greater than 0. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase [Baseline up to Week 12]
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase [Week 12 up to Week 26 (including 2 weeks of follow up after last dose)]
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.
- Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
Visual acuity (VA) was assessed using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.
- Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase [Baseline, Week 24]
VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.
- Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The visual accommodation was the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.
- Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase [Baseline, Week 24]
The visual accommodation is the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.
- Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.
- Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase [Baseline, Week 24]
CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.
- Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.
- Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase [Baseline, Week 24]
CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.
- Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
- Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase [Baseline, Week 24]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
- Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
- Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase [Baseline, Week 24]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
- Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
- Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase [Baseline, Week 24]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
- Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
- Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase [Baseline, Week 24]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
- Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
- Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase [Baseline, Week 24]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
- Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 12]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
- Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase [Baseline, Week 24]
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
- Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase [Baseline up to Week 12]
Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm.
- Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase [Baseline up to Week 24]
Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm.
- Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase [Week 1 up to Week 12]
Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 colony forming unit per milliliter [CFU/mL]) and the presence of symptoms, or pyuria (defined as >50 white blood cells [WBC] per high-pass filter [hpf]) and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participant with a documented history of vesicoureteral reflux (VUR).
- Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase [Week 12 up to Week 26]
Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) and the presence of symptoms, or pyuria (defined as >50 WBC per hpf and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participants with a documented history of VUR.
- Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase [Week 1 up to Week 12]
Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets<0.5*LLN>1.75*upper limit of normal (ULN), leukocytes <0.6*LLN>1.5*ULN, lymphocytes, neutrophils, <0.8*LLN >1.2*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, phosphate <0.8*LLN >1.2*ULN, blood urea nitrogen, creatinine >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN, potassium, chloride, calcium bicarbonate<0.9*LLN>1.1*ULN, glucose<0.6*LLN>1.5*ULN, creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20.
- Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase [Week 12 up to Week 26]
Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets<0.5*LLN>1.75*upper limit of normal (ULN), leukocytes <0.6*LLN>1.5*ULN, lymphocytes, neutrophils, <0.8*LLN >1.2*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, phosphate <0.8*LLN >1.2*ULN, blood urea nitrogen, creatinine >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN, potassium, chloride, calcium bicarbonate<0.9*LLN>1.1*ULN, glucose<0.6*LLN>1.5*ULN, creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20.
- Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase [Baseline, Week 4, 12]
Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study.
- Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase [Baseline, Week 24]
Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study.
- Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase [Baseline up to Week 12]
Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.
- Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase [Baseline up to Week 24]
Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.
- Absorption Rate Constant (Ka) of Fesoterodine [Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)]
Absorption rate constant is used to determine rate at which drug is entering into body. Pharmacokinetic (PK) analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
- Apparent Oral Clearance (CL/F) of Fesoterodine [Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)]
Clearance determines the rate at which a drug is metabolized or eliminated by normal biological processes. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
- Volume of Distribution (Vd) of Fesoterodine [Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects aged 6 to 17 years old
-
Subjects with stable neurological disease and neurogenic detrusor overactivity
-
Subjects using clean intermittent catheterization may participate
Exclusion Criteria:
-
Concomitant medications which may increase the risk to subjects or confound study results
-
Other medical conditions which may increase the risk to subjects or confound study results
-
Contraindications to the use of fesoterodine or oxybutynin
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urological Associates of Southern Arizona | Tucson | Arizona | United States | 85715 |
| 2 | Childrens Hospital of Orange County | Orange | California | United States | 92868 |
| 3 | CHOC Children's Urology Center | Orange | California | United States | 92868 |
| 4 | Children's Healthcare of Atlanta | Atlanta | Georgia | United States | 30342 |
| 5 | Georgia Urology, P.A. | Atlanta | Georgia | United States | 30342 |
| 6 | Judson L. Hawk Jr. M.D. | Atlanta | Georgia | United States | 30342 |
| 7 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 8 | Loyola University Outpatient Center | Maywood | Illinois | United States | 60153 |
| 9 | The Iowa Clinic | West Des Moines | Iowa | United States | 50266 |
| 10 | UNC Chapel Hill Memorial Hospital | Chapel Hill | North Carolina | United States | 27514 |
| 11 | UNC Memorial Hospital Pediatric Clinic | Chapel Hill | North Carolina | United States | 27514 |
| 12 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 13 | Cincinnati Children's Hospital Medical Center | Liberty Township | Ohio | United States | 45044 |
| 14 | Advanced Radiology | East Providence | Rhode Island | United States | 02914 |
| 15 | Pharma Resource | East Providence | Rhode Island | United States | 02915 |
| 16 | University Urological Associates, Inc | Providence | Rhode Island | United States | 02904 |
| 17 | University Urological Associates, Inc. | Providence | Rhode Island | United States | 02905 |
| 18 | Children's Hospital of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 19 | Universitair Ziekenhuis Antwerpen, Urologie | Edegem | Antwerpen | Belgium | 2650 |
| 20 | Hôpital Universitaire des Enfants Reine Fabiola | Bruxelles | Bruxelles-capitale | Belgium | 1020 |
| 21 | Centre hospitalier universitaire (CHU) Sainte-Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 22 | Tallinn Children's Hospital | Tallinn | Estonia | 13419 | |
| 23 | Tampere University Hospital | Tampere | Finland | 33520 | |
| 24 | Centre d'Investigation Clinique | Bron Cedex | France | 69677 | |
| 25 | Groupement Hospitalier Est - Hopital Femme Mere Enfant | Bron Cedex | France | 69677 | |
| 26 | Hôpitaux Pédiatriques de Nice CHU-Lenval | Nice | France | 06200 | |
| 27 | Kliniken Maria Hilf GmbH | Mönchengladbach | Nordrhein-westfalen | Germany | 41063 |
| 28 | University General Hospital of Larisa/ Urology Department | Larissa | Greece | 41110 | |
| 29 | Aristotle University of Thessaloniki | Thessaloniki | Greece | 56429 | |
| 30 | Department of Pediatrics, Christian Medical College and Hospital | Ludhiana | Punjab | India | 141 008 |
| 31 | I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" - Dipartimento Scienze Chirurgiche | San Giovanni Rotondo | Foggia | Italy | 71013 |
| 32 | Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna- | Cagliari | Italy | 09134 | |
| 33 | Azienda Ospedaliera Universitaria Careggi | Firenze | Italy | 50139 | |
| 34 | IRCCS Ospedale Pediatrico Bambino Gesù | Roma | Italy | 00165 | |
| 35 | ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza | Vicenza | Italy | 36100 | |
| 36 | Aichi Children's Health and Medical Center | Obu | Aichi | Japan | 474 8710 |
| 37 | Chiba Children's Hospital | Chiba-shi | Chiba, Japan | Japan | 266-0007 |
| 38 | Fukuoka Children's Hospital | Fukuoka-shi | Fukuoka | Japan | 813-0017 |
| 39 | Hokkaido University Hospital | Sapporo | Hokkaido | Japan | 060-8648 |
| 40 | Hyogo prefectural Kobe Children's Hospital | Kobe | Hyogo | Japan | 650-0047 |
| 41 | Kanagawa Children's Medical Center | Yokohama | Kanagawa | Japan | 232-8555 |
| 42 | Shinshu University Hospital | Matsumoto | Nagano | Japan | 3908621 |
| 43 | Osaka Medical Center and Research Institute for Maternal and Child Health | Izumi-shi | Osaka | Japan | 594-1101 |
| 44 | Dokkyo Medical University Koshigaya Hospital | Koshigaya | Saitama | Japan | 343-8555 |
| 45 | Shizuoka Children's Hospital | Shizuoka-shi | Shizuoka | Japan | 420 8660 |
| 46 | Dokkyo Medical University Hospital / Urology | Shimotsuga-gun | Tochigi | Japan | 321 0293 |
| 47 | Jichi Medical University Hospital | Shimotsuke | Tochigi | Japan | 329 0498 |
| 48 | The University of Tokyo Hospital / Urology | Bunkyo-ku | Tokyo | Japan | 113-8655 |
| 49 | Pusan National University Yangsan Hospital | Yangsan-si | Gyeongsangnam-do | Korea, Republic of | 50612 |
| 50 | Korea University Guro Hospital | Seoul | Korea | Korea, Republic of | 08308 |
| 51 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 52 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
| 53 | ASAN Medical Center | Seoul | Korea, Republic of | 05505 | |
| 54 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 55 | Hospital of Lithuanian University of Health Sciences Kaunas klinikos | Kaunas | Lithuania | LT-50161 | |
| 56 | Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos | Vilnius | Lithuania | LT-08406 | |
| 57 | Hospital Selayang | Batu Caves | Selangor | Malaysia | 68100 |
| 58 | Hospital Kuala Lumpur | Kuala Lumpur | Malaysia | 50586 | |
| 59 | Philippine Children's Medical Center | Quezon City | NCR | Philippines | 1100 |
| 60 | Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy | Gdansk | Poland | 80-952 | |
| 61 | Specjalistyczny Gabinet Lekarski Paweł Kroll | Poznan | Poland | 61-512 | |
| 62 | Kazan State Medical University | Kazan | Republic OF Tatarstan | Russian Federation | 420012 |
| 63 | Children's Republican Clinical Hospital, Department of Pediatric Surgery | Kazan | Russian Federation | 420138 | |
| 64 | Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical | Moscow | Russian Federation | 105425 | |
| 65 | FGBNU Scientific center of children health | Moscow | Russian Federation | 119991 | |
| 66 | SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO | Moscow | Russian Federation | 125412 | |
| 67 | J. BREZA MEDICAL s.r.o. | Bratislava | Slovakia | 831 01 | |
| 68 | Narodny ustav detskych chorob | Bratislava | Slovakia | 833 40 | |
| 69 | Red Cross Children's Hospital | Cape Town | Western CAPE | South Africa | 7700 |
| 70 | Hospital Sant Joan de Deu | Esplugues de Llobregat | Barcelona | Spain | 08950 |
| 71 | Hospital General Universitario Gregorio Marañon | Madrid | Spain | 28007 | |
| 72 | Hospital Infantil Universitario Niño Jesus | Madrid | Spain | 28009 | |
| 73 | Hospital Regional Universitario Carlos Haya | Malaga | Spain | 29011 | |
| 74 | Hospital Universitari i Politecnic La Fe | Valencia | Spain | 46026 | |
| 75 | Akademiska barnsjukhuset | Uppsala | Sweden | 751 85 | |
| 76 | Universitäts-Kinderspital beider Basel | Basel | Switzerland | 4031 | |
| 77 | National Cheng Kung University Hospital | Tainan | Taiwan | 704 | |
| 78 | Necmettin Erbakan Universitesi Meram Tip Fakultesi | Konya | Konya / Turkey | Turkey | 42080 |
| 79 | Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi | Ankara | Turkey | 06100 | |
| 80 | Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali | Ankara | Turkey | 06100 | |
| 81 | Istanbul Universitesi Istanbul Tip Fakultesi | Istanbul | Turkey | 34390 | |
| 82 | Leicester Royal Infirmary | Leicester | United Kingdom | LE1 5WW | |
| 83 | Alder Hey Children's Hospital | Liverpool | United Kingdom | L12 2AP | |
| 84 | Sheffield Children's NHS Foundation Trust | Sheffield | United Kingdom | S10 2TH |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01557244
Other Study ID Numbers:
- A0221047
- 2010-022475-55
First Posted:
Mar 19, 2012
Last Update Posted:
Feb 2, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Study had 2 cohorts: cohort 1 had participants with body weight greater than (>) 25 kilogram (kg) and cohort 2 had participants with body weight less than or equal to (<=) 25 kg. There were 2 phases in each cohort: cohort 1- active comparator phase followed by safety extension phase; cohort 2- efficacy phase followed by safety extension phase. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort 1: Fesoterodine 4 mg | Cohort 1: Fesoterodine 4 mg Then 8 mg | Cohort 1: Oxybutynin | Cohort 1: Oxybutynin Then Fesoterodine 4 mg | Cohort 1: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2: Fesoterodine 2 mg | Cohort 2: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 milligram (mg) prolonged release (PR) tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks. | Participants with body weight >25 kg were randomized to receive oxybutynin extended release (ER) tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks. |
| Period Title: Active Comparator/Efficacy Phase:12Weeks | |||||||
| STARTED | 42 | 42 | 40 | 0 | 0 | 28 | 29 |
| Treated | 42 | 42 | 40 | 0 | 0 | 28 | 29 |
| COMPLETED | 33 | 40 | 36 | 0 | 0 | 21 | 28 |
| NOT COMPLETED | 9 | 2 | 4 | 0 | 0 | 7 | 1 |
| Period Title: Active Comparator/Efficacy Phase:12Weeks | |||||||
| STARTED | 33 | 40 | 0 | 16 | 20 | 21 | 28 |
| Treated | 30 | 37 | 0 | 16 | 20 | 20 | 28 |
| COMPLETED | 30 | 36 | 0 | 15 | 20 | 20 | 28 |
| NOT COMPLETED | 3 | 4 | 0 | 1 | 0 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Cohort 1: Fesoterodine 4 mg | Cohort 1: Fesoterodine 4 mg Then 8 mg | Cohort 1: Oxybutynin | Cohort 2: Fesoterodine 2 mg | Cohort 2: Fesoterodine 2 mg Then 4 mg | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks. | Total of all reporting groups |
| Overall Participants | 42 | 42 | 40 | 28 | 29 | 181 |
| Age, Customized (Count of Participants) | ||||||
| >=6-9 Years |
15
35.7%
|
15
35.7%
|
15
37.5%
|
24
85.7%
|
23
79.3%
|
92
50.8%
|
| >=10-12 Years |
15
35.7%
|
14
33.3%
|
13
32.5%
|
3
10.7%
|
5
17.2%
|
50
27.6%
|
| >=13-17 Years |
12
28.6%
|
13
31%
|
12
30%
|
1
3.6%
|
1
3.4%
|
39
21.5%
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
16
38.1%
|
22
52.4%
|
17
42.5%
|
12
42.9%
|
19
65.5%
|
86
47.5%
|
| Male |
26
61.9%
|
20
47.6%
|
23
57.5%
|
16
57.1%
|
10
34.5%
|
95
52.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
3
7.1%
|
2
4.8%
|
1
2.5%
|
0
0%
|
2
6.9%
|
8
4.4%
|
| Not Hispanic or Latino |
39
92.9%
|
40
95.2%
|
39
97.5%
|
28
100%
|
27
93.1%
|
173
95.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
14
33.3%
|
18
42.9%
|
22
55%
|
16
57.1%
|
16
55.2%
|
86
47.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
4.8%
|
0
0%
|
1
2.5%
|
0
0%
|
0
0%
|
3
1.7%
|
| White |
24
57.1%
|
24
57.1%
|
17
42.5%
|
12
42.9%
|
11
37.9%
|
88
48.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
4.8%
|
0
0%
|
0
0%
|
0
0%
|
2
6.9%
|
4
2.2%
|
Outcome Measures
| Title | Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O). |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 41 | 41 | 38 | 25 | 28 |
| Least Squares Mean (95% Confidence Interval) [milliliter] |
58.12
|
83.36
|
87.17
|
23.49
|
40.17
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an analysis of covariance (ANCOVA) model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Least square (LS) Mean |
| Estimated Value | -29.06 | |
| Confidence Interval |
(2-Sided) 95% -71.42 to 13.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -3.82 | |
| Confidence Interval |
(2-Sided) 95% -45.87 to 38.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 40 | 41 | 38 | 25 | 28 |
| Least Squares Mean (95% Confidence Interval) [cm H2O] |
-2.86
|
-1.57
|
-2.39
|
-2.74
|
-9.73
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2334 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5087 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3333 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -0.47 | |
| Confidence Interval |
(2-Sided) 95% -7.28 to 6.33 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 0.82 | |
| Confidence Interval |
(2-Sided) 95% -5.96 to 7.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | In this outcome measure, shift data have been reported using 4 categories: (1) number of participants who did not have IDC at Baseline and at Week 12, (2) number of participants who did not have IDC at Baseline but had IDC at Week 12, (3) number of participants who had IDC at Baseline but no IDC at Week 12, and (4) number of participants who had IDC at Baseline and at Week 12. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 41 | 41 | 38 | 25 | 28 |
| Baseline IDC = No; Week 12 IDC = No |
12
28.6%
|
4
9.5%
|
6
15%
|
0
0%
|
1
3.4%
|
| Baseline IDC = No; Week 12 IDC = Yes |
2
4.8%
|
1
2.4%
|
0
0%
|
0
0%
|
0
0%
|
| Baseline IDC = Yes; Week 12 IDC = No |
9
21.4%
|
18
42.9%
|
14
35%
|
6
21.4%
|
11
37.9%
|
| Baseline IDC = Yes; Week 12 IDC = Yes |
18
42.9%
|
18
42.9%
|
18
45%
|
19
67.9%
|
16
55.2%
|
| Title | Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | Bladder volume (in milliliter) at first IDC was measured using urodynamic testing. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 26 | 36 | 32 | 25 | 27 |
| Least Squares Mean (95% Confidence Interval) [milliliter] |
30.53
|
26.06
|
41.31
|
23.80
|
31.26
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0336 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0327 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0017 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -10.78 | |
| Confidence Interval |
(2-Sided) 95% -48.75 to 27.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -15.25 | |
| Confidence Interval |
(2-Sided) 95% -50.15 to 19.64 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated). |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 40 | 40 | 38 | 25 | 28 |
| Least Squares Mean (95% Confidence Interval) [mL per cm H2O] |
6.40
|
5.41
|
11.36
|
12.44
|
16.44
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0679 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1233 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0019 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -4.96 | |
| Confidence Interval |
(2-Sided) 95% -14.81 to 4.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -5.95 | |
| Confidence Interval |
(2-Sided) 95% -15.85 to 3.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with >0 micturitions at Baseline. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 18 | 21 | 26 | 14 | 17 |
| Least Squares Mean (95% Confidence Interval) [micturitions per 24 hours] |
-1.07
|
-0.68
|
-0.97
|
-0.37
|
-0.70
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0116 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0765 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0061 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -1.16 to 0.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.74 to 1.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 catheterizations at Baseline. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 37 | 33 | 31 | 22 | 24 |
| Least Squares Mean (95% Confidence Interval) [catheterizations per 24 hours] |
-0.30
|
-0.32
|
-0.34
|
-0.10
|
-0.22
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0787 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0727 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0666 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to 0.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to 0.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The mean number of micturitions or catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hrs) period. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 41 | 37 | 38 | 23 | 26 |
| Least Squares Mean (95% Confidence Interval) [micturitions and catheterizations/24 hrs] |
-0.61
|
-0.60
|
-0.75
|
-0.24
|
-0.28
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0111 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0171 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0028 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to 0.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.54 to 0.84 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 incontinence episodes at Baseline. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 33 | 33 | 35 | 22 | 20 |
| Least Squares Mean (95% Confidence Interval) [incontinence episodes per 24 hours] |
-0.46
|
-0.89
|
-1.01
|
-0.38
|
-0.69
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0496 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 0.55 | |
| Confidence Interval |
(2-Sided) 95% -0.09 to 1.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.52 to 0.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for participants with >0 urgency episodes at Baseline. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 26 | 18 | 26 | 13 | 9 |
| Least Squares Mean (95% Confidence Interval) [urgency episodes per 24 hours] |
-0.62
|
-0.50
|
-0.14
|
-0.23
|
-0.62
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0298 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1417 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6219 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -0.48 | |
| Confidence Interval |
(2-Sided) 95% -1.28 to 0.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -0.36 | |
| Confidence Interval |
(2-Sided) 95% -1.24 to 0.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 15 | 15 | 20 | 8 | 10 |
| Least Squares Mean (95% Confidence Interval) [milliliter per micturition] |
4.10
|
19.21
|
4.15
|
-12.72
|
-8.41
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7986 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2313 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7571 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -42.11 to 42.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 15.07 | |
| Confidence Interval |
(2-Sided) 95% -26.50 to 56.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume greater than 0. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 36 | 32 | 28 | 23 | 25 |
| Least Squares Mean (95% Confidence Interval) [milliliter per catheterization] |
29.47
|
47.18
|
45.90
|
11.50
|
1.74
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0610 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0048 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0100 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -16.43 | |
| Confidence Interval |
(2-Sided) 95% -63.14 to 30.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 1.28 | |
| Confidence Interval |
(2-Sided) 95% -46.00 to 48.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume greater than 0. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 39 | 38 | 38 | 24 | 28 |
| Least Squares Mean (95% Confidence Interval) [mL per micturition or catheterization] |
18.45
|
55.55
|
36.69
|
7.12
|
-2.65
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2246 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0161 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | -18.24 | |
| Confidence Interval |
(2-Sided) 95% -61.00 to 24.53 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean |
| Estimated Value | 18.86 | |
| Confidence Interval |
(2-Sided) 95% -22.93 to 60.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events. |
| Time Frame | Baseline up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 42 | 42 | 40 | 28 | 29 |
| Treatment Emergent AEs |
26
61.9%
|
20
47.6%
|
30
75%
|
19
67.9%
|
18
62.1%
|
| Treatment Emergent SAEs |
3
7.1%
|
2
4.8%
|
1
2.5%
|
2
7.1%
|
2
6.9%
|
| Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events. |
| Time Frame | Week 12 up to Week 26 (including 2 weeks of follow up after last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 30 | 37 | 16 | 20 | 20 | 28 |
| Treatment emergent AEs |
14
33.3%
|
13
31%
|
9
22.5%
|
11
39.3%
|
11
37.9%
|
16
8.8%
|
| Treatment emergent SAEs |
0
0%
|
2
4.8%
|
0
0%
|
0
0%
|
0
0%
|
2
1.1%
|
| Title | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | Visual acuity (VA) was assessed using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 42 | 42 | 40 | 28 | 29 |
| Right Eye: Baseline |
0.09
(0.16)
|
0.11
(0.19)
|
0.03
(0.11)
|
0.15
(0.21)
|
0.10
(0.18)
|
| Right Eye: Change at Week 12 |
0.01
(0.11)
|
-0.01
(0.10)
|
0.02
(0.18)
|
0.03
(0.12)
|
-0.00
(0.09)
|
| Left Eye: Baseline |
0.08
(0.16)
|
0.10
(0.17)
|
0.02
(0.13)
|
0.16
(0.21)
|
0.14
(0.30)
|
| Left Eye: Change at Week 12 |
0.00
(0.13)
|
-0.01
(0.10)
|
0.00
(0.13)
|
-0.02
(0.08)
|
0.00
(0.08)
|
| Title | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase |
|---|---|
| Description | VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 30 | 37 | 16 | 20 | 20 | 28 |
| Right Eye: Change at Week 24 |
0.04
(0.17)
|
-0.02
(0.11)
|
-0.01
(0.05)
|
0.02
(0.13)
|
0.00
(0.07)
|
0.01
(0.11)
|
| Left Eye: Change at Week 24 |
0.01
(0.19)
|
-0.01
(0.11)
|
0.00
(0.08)
|
-0.04
(0.09)
|
-0.02
(0.07)
|
0.03
(0.13)
|
| Title | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The visual accommodation was the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 42 | 42 | 40 | 28 | 29 |
| Right Eye: Baseline |
11.88
(7.39)
|
15.94
(18.64)
|
9.59
(5.05)
|
9.67
(16.71)
|
8.17
(6.89)
|
| Right Eye: Change at Week 12 |
1.74
(7.45)
|
7.77
(45.53)
|
0.50
(4.64)
|
-1.04
(6.79)
|
1.02
(3.89)
|
| Left Eye: Baseline |
12.31
(8.67)
|
15.83
(17.85)
|
9.69
(5.13)
|
8.81
(14.89)
|
8.04
(7.17)
|
| Left Eye: Change at Week 12 |
0.27
(4.29)
|
5.79
(36.75)
|
0.81
(4.78)
|
-1.45
(9.60)
|
0.90
(3.38)
|
| Title | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase |
|---|---|
| Description | The visual accommodation is the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 30 | 37 | 16 | 20 | 20 | 28 |
| Right Eye: Change at Week 24 |
0.73
(5.47)
|
4.33
(28.89)
|
1.50
(4.80)
|
0.50
(4.30)
|
-1.35
(13.03)
|
0.96
(4.38)
|
| Left Eye: Change at Week 24 |
0.90
(5.85)
|
3.79
(29.81)
|
1.66
(6.25)
|
0.58
(4.53)
|
0.43
(11.53)
|
1.12
(4.20)
|
| Title | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 42 | 42 | 40 | 28 | 29 |
| Aggressive behavior: Baseline |
53.86
(5.67)
|
54.32
(5.88)
|
54.58
(5.75)
|
54.9
(5.25)
|
52.8
(4.48)
|
| Aggressive behavior: Change at Week 12 |
-1.03
(3.17)
|
-0.95
(3.71)
|
-1.28
(2.77)
|
-1.29
(3.58)
|
-0.03
(2.96)
|
| Anxious/depressed: Baseline |
56.07
(6.99)
|
57.00
(8.26)
|
56.75
(7.32)
|
55.5
(6.58)
|
56.3
(6.55)
|
| Anxious/depressed: Change at Week 12 |
-1.73
(3.05)
|
-1.38
(5.25)
|
-1.92
(4.66)
|
-0.79
(4.55)
|
-3.21
(5.27)
|
| Attention problems: Baseline |
56.29
(5.32)
|
56.66
(7.47)
|
56.30
(5.68)
|
55.4
(5.06)
|
55.3
(5.74)
|
| Attention problems: Change at week 12 |
-1.97
(3.79)
|
-1.40
(4.30)
|
-1.28
(3.69)
|
-1.29
(3.61)
|
-1.45
(3.41)
|
| Rule-breaking behavior: Baseline |
53.26
(3.52)
|
53.80
(5.53)
|
53.43
(4.96)
|
54.5
(4.96)
|
52.3
(3.74)
|
| Rule-breaking behavior: Change at Week 12 |
-0.92
(2.99)
|
-0.88
(3.91)
|
-0.72
(2.76)
|
-1.71
(4.84)
|
-0.10
(2.19)
|
| Social problems : Baseline |
57.52
(5.42)
|
58.54
(9.43)
|
57.95
(7.90)
|
57.9
(6.66)
|
55.8
(5.90)
|
| Social problems : Change at Week 12 |
-1.35
(3.90)
|
-2.55
(4.74)
|
-0.67
(3.73)
|
-2.21
(4.38)
|
-1.10
(3.41)
|
| Somatic complaints: Baseline |
61.14
(6.24)
|
60.46
(8.73)
|
60.58
(8.44)
|
57.1
(6.47)
|
58.4
(6.55)
|
| Somatic complaints: Change at Week 12 |
-0.46
(5.99)
|
-1.28
(6.35)
|
-0.87
(7.16)
|
-0.38
(3.97)
|
-1.69
(5.90)
|
| Thought problems: Baseline |
55.00
(6.19)
|
53.54
(5.93)
|
56.73
(7.64)
|
51.9
(2.81)
|
54.9
(5.60)
|
| Thought problems: Change at Week 12 |
-0.92
(4.69)
|
-0.48
(4.25)
|
-1.59
(3.65)
|
-0.42
(1.67)
|
-1.38
(5.42)
|
| Withdrawn: Baseline |
54.60
(5.17)
|
57.54
(8.34)
|
58.25
(7.93)
|
55.7
(5.96)
|
55.0
(7.11)
|
| Withdrawn: Change at Week 12 |
0.35
(4.70)
|
-1.25
(5.13)
|
-1.92
(5.08)
|
-1.75
(3.97)
|
-0.59
(4.48)
|
| Externalizing: Baseline |
49.48
(8.68)
|
49.46
(10.00)
|
50.10
(9.73)
|
51.1
(9.83)
|
48.0
(7.84)
|
| Externalizing: Change at Week 12 |
-2.08
(5.26)
|
-2.33
(5.28)
|
-1.95
(4.62)
|
-2.63
(4.72)
|
-1.45
(4.56)
|
| Internalizing: Baseline |
56.45
(8.06)
|
55.93
(12.84)
|
57.25
(11.00)
|
53.9
(10.34)
|
54.6
(10.14)
|
| Internalizing: Change at Week 12 |
-2.14
(6.46)
|
-2.35
(6.98)
|
-3.05
(7.12)
|
-1.96
(6.53)
|
-3.52
(6.38)
|
| Total Problems: Baseline |
55.05
(8.20)
|
53.61
(11.98)
|
55.45
(10.28)
|
53.4
(10.70)
|
52.7
(9.37)
|
| Total Problems: Change at Week 12 |
-2.51
(4.63)
|
-3.23
(5.45)
|
-2.36
(4.68)
|
-2.17
(5.05)
|
-3.38
(4.55)
|
| Title | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase |
|---|---|
| Description | CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 30 | 37 | 16 | 20 | 20 | 28 |
| Aggressive behavior: Change at Week 24 |
-1.59
(3.85)
|
-1.31
(4.57)
|
-1.25
(3.40)
|
-2.40
(4.89)
|
-1.70
(3.40)
|
-1.86
(3.63)
|
| Anxious/depressed: Change at Week 24 |
-3.45
(4.86)
|
-2.31
(5.64)
|
-1.50
(3.76)
|
-3.25
(5.66)
|
-2.60
(5.24)
|
-3.89
(4.95)
|
| Attention problems: Change at Week 24 |
-2.21
(3.99)
|
-2.64
(5.72)
|
-3.38
(4.65)
|
-1.70
(3.01)
|
-1.50
(3.15)
|
-1.71
(3.29)
|
| Rule-breaking behavior: Change at Week 24 |
-1.59
(3.62)
|
-1.47
(5.12)
|
-1.31
(4.01)
|
-0.90
(2.36)
|
-2.15
(3.17)
|
-0.36
(2.63)
|
| Social problems : Change at Week 24 |
-2.83
(4.12)
|
-2.56
(4.15)
|
-3.19
(5.79)
|
-2.65
(3.28)
|
-3.90
(4.35)
|
-2.36
(4.17)
|
| Somatic complaints: Change at Week 24 |
-4.38
(6.59)
|
-2.64
(6.58)
|
-1.69
(9.20)
|
-1.50
(5.82)
|
-0.60
(3.12)
|
-1.96
(6.77)
|
| Thought problems: Change at Week 24 |
-3.10
(5.45)
|
-1.03
(4.52)
|
-3.25
(6.62)
|
-2.30
(3.50)
|
-1.40
(3.00)
|
-1.75
(3.99)
|
| Withdrawn: Change at Week 24 |
-0.69
(4.33)
|
-1.50
(5.98)
|
-2.19
(3.90)
|
-4.35
(5.24)
|
-1.80
(5.43)
|
-0.43
(3.75)
|
| Externalizing: Change at Week 24 |
-5.21
(8.20)
|
-2.89
(7.06)
|
-1.81
(5.42)
|
-4.15
(7.44)
|
-4.20
(5.15)
|
-4.21
(6.86)
|
| Internalizing: Change at Week 24 |
-7.69
(7.46)
|
-4.14
(7.62)
|
-3.25
(8.10)
|
-5.35
(7.21)
|
-4.40
(6.21)
|
-4.32
(6.70)
|
| Total Problems: Change at Week 24 |
-7.03
(7.77)
|
-4.44
(6.57)
|
-3.69
(6.74)
|
-4.90
(4.78)
|
-5.20
(4.32)
|
-5.25
(6.22)
|
| Title | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 42 | 42 | 40 | 28 | 29 |
| Aggressive behavior: Baseline |
4.19
(4.39)
|
4.66
(4.46)
|
4.88
(4.35)
|
5.1
(3.95)
|
3.5
(3.37)
|
| Aggressive behavior: Change at Week 12 |
-0.62
(2.35)
|
-0.90
(2.56)
|
-0.97
(2.08)
|
-0.92
(2.39)
|
-0.17
(1.85)
|
| Anxious/depressed: Baseline |
3.83
(3.33)
|
4.20
(4.06)
|
4.10
(3.53)
|
3.8
(3.15)
|
4.0
(3.35)
|
| Anxious/depressed: Change at Week 12 |
-0.97
(1.46)
|
-0.73
(2.43)
|
-1.05
(2.26)
|
-0.58
(2.28)
|
-1.48
(2.43)
|
| Attention problems: Baseline |
4.79
(3.18)
|
4.49
(4.11)
|
4.85
(3.33)
|
4.2
(2.78)
|
3.9
(3.11)
|
| Attention problems: Change at Week 12 |
-1.05
(2.25)
|
-0.73
(2.16)
|
-0.77
(2.03)
|
-0.71
(1.90)
|
-0.83
(1.63)
|
| Rule-breaking behavior: Baseline |
1.64
(1.48)
|
1.66
(1.98)
|
1.70
(1.87)
|
1.9
(1.63)
|
1.0
(1.30)
|
| Rule-breaking behavior: Change at Week 12 |
-0.43
(1.09)
|
-0.30
(1.36)
|
-0.38
(0.99)
|
-0.63
(1.56)
|
0.52
(3.45)
|
| Social problems: Baseline |
3.60
(2.30)
|
4.07
(4.12)
|
3.80
(3.36)
|
3.9
(2.99)
|
3.2
(2.64)
|
| Social problems: Change at Week 12 |
-0.54
(1.54)
|
-1.13
(2.09)
|
-0.26
(1.57)
|
-0.83
(1.86)
|
-0.62
(1.52)
|
| Somatic complaints: Baseline |
3.40
(2.18)
|
3.46
(3.26)
|
3.40
(3.23)
|
2.1
(1.93)
|
2.6
(2.16)
|
| Somatic complaints: Change at Week 12 |
-0.05
(2.26)
|
-0.53
(2.44)
|
-0.51
(2.64)
|
-0.04
(1.55)
|
-0.55
(2.03)
|
| Thought problems: Baseline |
2.05
(2.23)
|
1.46
(2.34)
|
2.58
(2.92)
|
1.0
(1.04)
|
2.0
(1.79)
|
| Thought problems: Change at Week 12 |
-0.46
(1.69)
|
-0.10
(1.37)
|
-0.51
(1.30)
|
-0.21
(0.72)
|
-0.45
(1.64)
|
| Withdrawn: Baseline |
1.52
(1.77)
|
2.49
(2.78)
|
2.75
(2.66)
|
1.7
(1.81)
|
1.6
(2.26)
|
| Withdrawn: Change at Week 12 |
0.14
(1.44)
|
-0.35
(1.59)
|
-0.64
(1.77)
|
-0.50
(1.10)
|
-0.17
(1.39)
|
| Externalizing: Baseline |
5.83
(5.23)
|
6.32
(6.14)
|
6.53
(5.87)
|
6.9
(5.16)
|
4.5
(4.32)
|
| Externalizing: Change at Week 12 |
-1.05
(2.85)
|
-1.20
(3.42)
|
-1.31
(2.30)
|
-1.54
(3.50)
|
-0.31
(2.33)
|
| Internalizing: Baseline |
8.76
(5.56)
|
10.15
(8.64)
|
10.25
(7.02)
|
7.5
(5.61)
|
8.2
(6.13)
|
| Internalizing: Change at Week 12 |
-0.89
(3.62)
|
-1.70
(5.16)
|
-2.21
(4.35)
|
-1.13
(3.85)
|
-2.21
(3.91)
|
| Total Problems: Baseline |
31.52
(16.84)
|
31.88
(23.78)
|
34.18
(22.16)
|
29.5
(17.41)
|
27.0
(16.59)
|
| Total Problems: Change at Week 12 |
-4.92
(8.73)
|
-5.83
(12.16)
|
-5.85
(9.77)
|
-5.33
(8.29)
|
-5.10
(7.41)
|
| Title | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase |
|---|---|
| Description | CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 29 | 36 | 16 | 20 | 20 | 28 |
| Aggressive behavior: Change at Week 24 |
-1.34
(2.92)
|
-1.17
(3.10)
|
-0.81
(2.43)
|
-1.75
(3.58)
|
-1.40
(2.41)
|
-1.57
(2.70)
|
| Anxious/depressed: Change at Week 24 |
-1.93
(2.22)
|
-1.28
(2.42)
|
-1.06
(1.88)
|
-1.60
(2.48)
|
-1.70
(2.36)
|
-1.75
(2.34)
|
| Attention problems: Change at Week 24 |
-1.41
(2.31)
|
-1.36
(2.77)
|
-1.94
(2.35)
|
-1.25
(1.77)
|
-1.15
(1.76)
|
-0.89
(1.69)
|
| Rule-breaking behavior: Change at Week 24 |
-0.62
(1.29)
|
-0.50
(1.65)
|
-0.50
(1.21)
|
-0.55
(0.94)
|
-0.80
(1.01)
|
-0.18
(0.94)
|
| Social problems: Change at Week 24 |
-1.28
(1.53)
|
-1.19
(1.97)
|
-1.13
(2.33)
|
-1.20
(1.36)
|
-1.65
(1.81)
|
-1.14
(1.74)
|
| Somatic complaints: Change at Week 24 |
-1.34
(2.22)
|
-0.89
(2.38)
|
-0.88
(3.32)
|
-0.45
(1.73)
|
-0.15
(0.88)
|
-0.68
(2.04)
|
| Thought problems: Change at Week 24 |
-1.31
(1.95)
|
-0.36
(1.40)
|
-1.06
(2.14)
|
-0.90
(1.21)
|
-0.65
(1.04)
|
-0.64
(1.28)
|
| Withdrawn: Change at Week 24 |
-0.24
(1.43)
|
-0.44
(2.01)
|
-0.69
(1.35)
|
-1.35
(1.66)
|
-0.45
(1.50)
|
-0.14
(1.04)
|
| Externalizing: Change at Week 24 |
-1.97
(3.50)
|
-1.67
(4.27)
|
-1.19
(3.23)
|
-2.30
(4.03)
|
-2.20
(2.84)
|
-1.79
(3.28)
|
| Internalizing: Change at Week 24 |
-3.52
(4.00)
|
-2.61
(4.95)
|
-2.63
(4.65)
|
-3.40
(4.68)
|
-2.30
(3.64)
|
-2.57
(3.63)
|
| Total Problems: Change at Week 24 |
-10.90
(11.98)
|
-8.58
(12.86)
|
-9.00
(13.45)
|
-10.10
(10.47)
|
-9.45
(7.93)
|
-8.39
(10.22)
|
| Title | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 9 | 9 | 7 | 18 | 21 |
| Dominant hand: Baseline |
61.11
(31.66)
|
56.50
(32.09)
|
46.43
(16.28)
|
69.56
(58.52)
|
52.20
(31.06)
|
| Dominant hand: Change at Week 12 |
-7.71
(11.06)
|
10.14
(37.18)
|
-5.33
(6.15)
|
-11.20
(41.11)
|
-10.26
(27.21)
|
| Non-dominant hand: Baseline |
80.44
(41.45)
|
114.00
(89.43)
|
48.00
(15.14)
|
91.29
(110.76)
|
76.29
(76.71)
|
| Non-dominant hand: Change at Week 12 |
-21.71
(25.44)
|
15.33
(49.28)
|
-2.00
(12.25)
|
-19.36
(81.03)
|
-3.25
(22.53)
|
| Title | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 3 | 7 | 2 | 3 | 15 | 19 |
| Dominant hand: Change at Week 24 |
-11.33
(9.07)
|
-3.71
(22.94)
|
-2.00
(8.49)
|
-6.33
(3.06)
|
-7.07
(6.80)
|
-15.00
(28.54)
|
| Non-dominant hand: Change at Week 24 |
-2.00
(13.75)
|
-4.00
(29.09)
|
1.50
(10.61)
|
-11.00
(5.00)
|
-9.14
(14.33)
|
-18.47
(38.13)
|
| Title | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 33 | 34 | 33 | 10 | 9 |
| Dominant hand: Baseline |
88.85
(24.22)
|
92.15
(40.51)
|
82.64
(24.32)
|
106.7
(64.07)
|
124.7
(71.99)
|
| Dominant hand: Change at Week 12 |
-5.40
(10.43)
|
-8.88
(20.76)
|
1.21
(11.87)
|
-14.38
(25.90)
|
-18.44
(32.23)
|
| Non-dominant hand: Baseline |
110.61
(59.63)
|
109.00
(49.75)
|
92.94
(25.05)
|
130.30
(83.58)
|
126.1
(48.93)
|
| Non-dominant hand: Change at Week 12 |
-9.10
(19.94)
|
-4.10
(10.79)
|
-1.97
(14.00)
|
-13.50
(18.81)
|
-12.50
(20.30)
|
| Title | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 25 | 30 | 14 | 16 | 5 | 9 |
| Dominant hand: Change at Week 24 |
-8.20
(11.67)
|
-12.27
(18.28)
|
-5.71
(9.55)
|
-7.00
(13.25)
|
-38.20
(31.67)
|
-17.00
(33.16)
|
| Non-dominant hand: Change at Week 24 |
-9.24
(15.79)
|
-8.46
(10.42)
|
-3.79
(11.89)
|
-11.87
(14.15)
|
-38.00
(29.35)
|
-15.50
(29.11)
|
| Title | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 9 | 9 | 7 | 18 | 21 |
| Dominant hand: Baseline |
0.11
(0.33)
|
0.75
(1.75)
|
0.29
(0.49)
|
0.39
(1.24)
|
0.10
(0.45)
|
| Dominant hand: Change at Week 12 |
0.29
(0.76)
|
0.57
(1.13)
|
-0.17
(0.75)
|
0.00
(1.77)
|
0.05
(0.52)
|
| Non-dominant hand: Baseline |
0.44
(0.53)
|
1.22
(2.28)
|
0.00
(0.00)
|
0.35
(0.86)
|
0.76
(2.26)
|
| Non-dominant hand: Change at Week 12 |
0.43
(1.27)
|
1.00
(2.00)
|
0.17
(0.41)
|
0.00
(0.68)
|
0.60
(3.45)
|
| Title | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin 5 mg ER tablets orally once daily in active comparator phase, were allocated by investigator to receive fesoterodine 8 mg for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 3 | 7 | 2 | 3 | 15 | 19 |
| Dominant hand: Change at week 24 |
0.33
(0.58)
|
0.43
(0.79)
|
0.00
(0.00)
|
-0.33
(0.58)
|
-0.27
(1.39)
|
-0.06
(0.54)
|
| Non-dominant hand: Change at week 24 |
1.33
(2.31)
|
0.00
(1.10)
|
0.50
(0.71)
|
0.00
(0.00)
|
-0.36
(0.74)
|
0.11
(3.45)
|
| Title | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 33 | 34 | 33 | 10 | 9 |
| Dominant hand: Baseline |
0.45
(1.20)
|
0.24
(0.50)
|
0.24
(0.66)
|
0.10
(0.32)
|
0.11
(0.33)
|
| Dominant hand: Change at Week 12 |
0.00
(1.05)
|
-0.18
(0.58)
|
0.09
(0.77)
|
0.00
(0.53)
|
0.44
(1.33)
|
| Non-dominant hand: Baseline |
0.91
(2.36)
|
0.28
(0.46)
|
0.36
(0.78)
|
0.40
(0.97)
|
0.13
(0.35)
|
| Non-dominant hand: Change at Week 12 |
-0.33
(1.60)
|
0.06
(1.03)
|
0.21
(1.78)
|
0.13
(0.35)
|
0.00
(0.00)
|
| Title | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 25 | 30 | 14 | 16 | 5 | 9 |
| Dominant hand: Change at Week 24 |
0.00
(0.87)
|
0.63
(4.63)
|
0.14
(0.36)
|
0.25
(1.24)
|
0.00
(0.00)
|
0.44
(1.33)
|
| Non-dominant hand: Change at Week 24 |
-0.28
(2.17)
|
0.68
(4.79)
|
0.00
(0.39)
|
0.27
(1.67)
|
0.60
(0.89)
|
-0.13
(0.35)
|
| Title | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 9 | 9 | 7 | 18 | 21 |
| Dominant hand: Baseline |
9.56
(1.01)
|
9.38
(1.77)
|
10.00
(0.00)
|
9.89
(0.47)
|
10.0
(0.00)
|
| Dominant hand: Change at Week 12 |
-0.29
(0.76)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.38)
|
-0.11
(0.46)
|
| Non-dominant hand: Baseline |
9.56
(1.01)
|
9.00
(2.35)
|
10.00
(0.00)
|
9.82
(0.73)
|
9.62
(1.20)
|
| Non-dominant hand: Change at Week 12 |
-0.57
(1.13)
|
0.00
(0.00)
|
0.00
(0.00)
|
-0.07
(0.62)
|
0.00
(0.32)
|
| Title | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 3 | 7 | 2 | 3 | 15 | 19 |
| Dominant hand: Change at Week 24 |
-0.33
(0.58)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.07
(0.26)
|
0.00
(0.00)
|
| Non-dominant hand: Change at Week 24 |
-1.33
(2.31)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.14
(0.53)
|
0.21
(0.92)
|
| Title | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 33 | 34 | 33 | 10 | 9 |
| Dominant hand: Baseline |
25.00
(0.00)
|
24.56
(1.89)
|
25.00
(0.00)
|
25.00
(0.00)
|
23.22
(3.83)
|
| Dominant hand: Change at Week 12 |
-0.07
(0.25)
|
0.42
(1.77)
|
-0.12
(0.70)
|
-0.13
(0.35)
|
0.11
(2.76)
|
| Non-dominant hand: Baseline |
24.45
(2.09)
|
24.75
(0.92)
|
24.88
(0.42)
|
24.50
(1.58)
|
24.25
(1.75)
|
| Non-dominant hand: Change at Week 12 |
0.53
(2.19)
|
0.26
(0.93)
|
0.03
(0.30)
|
0.63
(1.77)
|
-0.63
(1.77)
|
| Title | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase |
|---|---|
| Description | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 25 | 30 | 14 | 16 | 5 | 9 |
| Dominant hand: Change at Week 24 |
0.00
(0.00)
|
0.50
(2.01)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.11
(2.76)
|
| Non-dominant hand: Change at Week 24 |
0.60
(2.40)
|
0.21
(0.96)
|
0.14
(0.66)
|
0.00
(0.00)
|
0.60
(2.61)
|
-0.50
(1.85)
|
| Title | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase |
|---|---|
| Description | Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm. |
| Time Frame | Baseline up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 40 | 41 | 40 | 24 | 29 |
| SBP: <90 mmHg |
2
4.8%
|
2
4.8%
|
0
0%
|
7
25%
|
4
13.8%
|
| SBP: Change >=30 mmHg increase |
1
2.4%
|
2
4.8%
|
1
2.5%
|
0
0%
|
1
3.4%
|
| SBP: Change >=30 mmHg decrease |
1
2.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| DBP: <50 mmHg |
2
4.8%
|
1
2.4%
|
2
5%
|
3
10.7%
|
1
3.4%
|
| DBP: Change >=20 mmHg increase |
1
2.4%
|
2
4.8%
|
1
2.5%
|
3
10.7%
|
4
13.8%
|
| DBP: Change >=20 mmHg decrease |
1
2.4%
|
1
2.4%
|
1
2.5%
|
2
7.1%
|
0
0%
|
| Pulse rate: <40 bpm |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Pulse rate: >120 bpm |
2
4.8%
|
4
9.5%
|
0
0%
|
2
7.1%
|
3
10.3%
|
| Title | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase |
|---|---|
| Description | Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm. |
| Time Frame | Baseline up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 30 | 37 | 16 | 20 | 20 | 28 |
| SBP: <90 mmHg |
0
0%
|
3
7.1%
|
2
5%
|
1
3.6%
|
4
13.8%
|
2
1.1%
|
| SBP: Change >=30 mmHg increase |
1
2.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| SBP: Change >=30 mmHg decrease |
0
0%
|
1
2.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| DBP: <50 mmHg |
0
0%
|
2
4.8%
|
0
0%
|
0
0%
|
2
6.9%
|
0
0%
|
| DBP: Change >=20 mmHg increase |
1
2.4%
|
0
0%
|
0
0%
|
0
0%
|
1
3.4%
|
2
1.1%
|
| DBP: Change >=20 mmHg decrease |
1
2.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Pulse rate: <40 bpm |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Pulse rate: >120 bpm |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.6%
|
| Title | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase |
|---|---|
| Description | Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 colony forming unit per milliliter [CFU/mL]) and the presence of symptoms, or pyuria (defined as >50 white blood cells [WBC] per high-pass filter [hpf]) and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participant with a documented history of vesicoureteral reflux (VUR). |
| Time Frame | Week 1 up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase of the study. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 42 | 42 | 40 | 28 | 29 |
| Count of Participants [Participants] |
4
9.5%
|
1
2.4%
|
4
10%
|
3
10.7%
|
4
13.8%
|
| Title | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase |
|---|---|
| Description | Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) and the presence of symptoms, or pyuria (defined as >50 WBC per hpf and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participants with a documented history of VUR. |
| Time Frame | Week 12 up to Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 30 | 37 | 16 | 20 | 20 | 28 |
| Count of Participants [Participants] |
0
0%
|
1
2.4%
|
2
5%
|
0
0%
|
1
3.4%
|
5
2.8%
|
| Title | Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase |
|---|---|
| Description | Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets<0.5*LLN>1.75*upper limit of normal (ULN), leukocytes <0.6*LLN>1.5*ULN, lymphocytes, neutrophils, <0.8*LLN >1.2*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, phosphate <0.8*LLN >1.2*ULN, blood urea nitrogen, creatinine >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN, potassium, chloride, calcium bicarbonate<0.9*LLN>1.1*ULN, glucose<0.6*LLN>1.5*ULN, creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20. |
| Time Frame | Week 1 up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 39 | 41 | 39 | 24 | 29 |
| Count of Participants [Participants] |
30
71.4%
|
29
69%
|
27
67.5%
|
19
67.9%
|
19
65.5%
|
| Title | Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase |
|---|---|
| Description | Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets<0.5*LLN>1.75*upper limit of normal (ULN), leukocytes <0.6*LLN>1.5*ULN, lymphocytes, neutrophils, <0.8*LLN >1.2*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, phosphate <0.8*LLN >1.2*ULN, blood urea nitrogen, creatinine >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN, potassium, chloride, calcium bicarbonate<0.9*LLN>1.1*ULN, glucose<0.6*LLN>1.5*ULN, creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20. |
| Time Frame | Week 12 up to Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 30 | 36 | 16 | 19 | 20 | 28 |
| Count of Participants [Participants] |
19
45.2%
|
22
52.4%
|
7
17.5%
|
12
42.9%
|
15
51.7%
|
21
11.6%
|
| Title | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase |
|---|---|
| Description | Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study. |
| Time Frame | Baseline, Week 4, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure; "Number Analyzed": participants evaluable at specified time points. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 6 | 7 | 9 | 6 | 6 |
| Baseline |
7.00
(8.20)
|
9.57
(12.54)
|
5.78
(7.98)
|
14.7
(14.31)
|
10.7
(7.94)
|
| Change at Week 4 |
5.40
(7.60)
|
-7.33
(10.88)
|
19.11
(24.52)
|
-2.00
(6.24)
|
10.25
(34.40)
|
| Change at Week 12 |
25.60
(53.42)
|
-4.00
(8.41)
|
12.86
(43.48)
|
2.50
(16.05)
|
0.75
(17.46)
|
| Title | Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase |
|---|---|
| Description | Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 4 | 5 | 5 | 3 | 3 | 4 |
| Mean (Standard Deviation) [milliliter] |
11.50
(23.67)
|
11.60
(29.43)
|
18.00
(31.36)
|
36.67
(59.23)
|
21.67
(20.21)
|
2.75
(14.50)
|
| Title | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase |
|---|---|
| Description | Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator. |
| Time Frame | Baseline up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase of the study. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. |
| Measure Participants | 38 | 42 | 40 | 28 | 29 |
| Count of Participants [Participants] |
2
4.8%
|
1
2.4%
|
1
2.5%
|
1
3.6%
|
0
0%
|
| Title | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase |
|---|---|
| Description | Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator. |
| Time Frame | Baseline up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study. |
| Arm/Group Title | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase: Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. |
| Measure Participants | 30 | 37 | 16 | 20 | 20 | 28 |
| Count of Participants [Participants] |
3
7.1%
|
2
4.8%
|
0
0%
|
0
0%
|
0
0%
|
2
1.1%
|
| Title | Absorption Rate Constant (Ka) of Fesoterodine |
|---|---|
| Description | Absorption rate constant is used to determine rate at which drug is entering into body. Pharmacokinetic (PK) analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach. |
| Time Frame | Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study. |
| Arm/Group Title | Fesoterodine Pooled |
|---|---|
| Arm/Group Description | Participants received any dose of fesoterodine in the study from Week 1 to Week 24. |
| Measure Participants | 121 |
| Mean (Standard Error) [per hour] |
0.0897
(5.99)
|
| Title | Apparent Oral Clearance (CL/F) of Fesoterodine |
|---|---|
| Description | Clearance determines the rate at which a drug is metabolized or eliminated by normal biological processes. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach. |
| Time Frame | Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study. |
| Arm/Group Title | Fesoterodine Pooled |
|---|---|
| Arm/Group Description | Participants received any dose of fesoterodine in the study from Week 1 to Week 24. |
| Measure Participants | 121 |
| Mean (Standard Error) [liter per hour] |
71.6
(6.7)
|
| Title | Volume of Distribution (Vd) of Fesoterodine |
|---|---|
| Description | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach. |
| Time Frame | Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study. |
| Arm/Group Title | Fesoterodine Pooled |
|---|---|
| Arm/Group Description | Participants received any dose of fesoterodine in the study from Week 1 to Week 24. |
| Measure Participants | 121 |
| Mean (Standard Error) [liter] |
68.1
(29.7)
|
Adverse Events
| Time Frame | Baseline up to Week 26 (includes 2 week of follow up) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. | |||||||||||||||||||||
| Arm/Group Title | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2 Efficacy Phase: Fesoterodine 4 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | |||||||||||
| Arm/Group Description | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. | Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase. | Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. | Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. | Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. | |||||||||||
All Cause Mortality |
||||||||||||||||||||||
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2 Efficacy Phase: Fesoterodine 4 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
Serious Adverse Events |
||||||||||||||||||||||
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2 Efficacy Phase: Fesoterodine 4 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/42 (7.1%) | 2/42 (4.8%) | 1/40 (2.5%) | 0/30 (0%) | 2/37 (5.4%) | 0/16 (0%) | 0/20 (0%) | 2/28 (7.1%) | 2/29 (6.9%) | 0/20 (0%) | 2/28 (7.1%) | |||||||||||
| Infections and infestations | ||||||||||||||||||||||
| Cellulitis | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Complicated appendicitis | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Epididymitis | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Peritonitis | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Pyelonephritis acute | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Urinary tract infection | 1/42 (2.4%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 1/29 (3.4%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Viral infection | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Appendicitis | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dengue fever | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||
| Animal bite | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||
| Epiphysiolysis | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Renal and urinary disorders | ||||||||||||||||||||||
| Acute kidney injury | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Hydronephrosis | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||||
| Ovarian cyst | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||
| Decubitus ulcer | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Cohort 1, Active Comparator Phase: Oxybutynin | Cohort 1, Safety Extension Phase: Fesoterodine 4 mg | Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg | Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg | Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg | Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Cohort 2 Efficacy Phase: Fesoterodine 4 mg | Cohort 2, Safety Extension Phase: Fesoterodine 2 mg | Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 26/42 (61.9%) | 19/42 (45.2%) | 30/40 (75%) | 14/30 (46.7%) | 13/37 (35.1%) | 9/16 (56.3%) | 11/20 (55%) | 19/28 (67.9%) | 17/29 (58.6%) | 11/20 (55%) | 14/28 (50%) | |||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||
| Thrombocytopenia | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Cardiac disorders | ||||||||||||||||||||||
| Supraventricular extrasystoles | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Tachycardia | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||||
| Vertigo positional | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Ear pain | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Eye disorders | ||||||||||||||||||||||
| Astigmatism | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Myopia | 1/42 (2.4%) | 1/42 (2.4%) | 1/40 (2.5%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Strabismus | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Vision blurred | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Accommodation disorder | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Eye pruritus | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Visual impairment | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||
| Abdominal pain | 1/42 (2.4%) | 1/42 (2.4%) | 2/40 (5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Abdominal pain upper | 2/42 (4.8%) | 1/42 (2.4%) | 2/40 (5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Constipation | 3/42 (7.1%) | 3/42 (7.1%) | 5/40 (12.5%) | 0/30 (0%) | 0/37 (0%) | 1/16 (6.3%) | 0/20 (0%) | 0/28 (0%) | 2/29 (6.9%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Diarrhoea | 5/42 (11.9%) | 3/42 (7.1%) | 1/40 (2.5%) | 1/30 (3.3%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 1/29 (3.4%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Dry mouth | 3/42 (7.1%) | 4/42 (9.5%) | 11/40 (27.5%) | 1/30 (3.3%) | 0/37 (0%) | 1/16 (6.3%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Faeces soft | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Lip dry | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Nausea | 2/42 (4.8%) | 1/42 (2.4%) | 2/40 (5%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Vomiting | 0/42 (0%) | 0/42 (0%) | 2/40 (5%) | 0/30 (0%) | 1/37 (2.7%) | 1/16 (6.3%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Toothache | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Abdominal discomfort | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Abdominal pain lower | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dental caries | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dysphagia | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Enteritis | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Flatulence | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Lip erythema | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Stomatitis | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| General disorders | ||||||||||||||||||||||
| Catheter site pain | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Fatigue | 1/42 (2.4%) | 0/42 (0%) | 1/40 (2.5%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Malaise | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Mass | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 1/16 (6.3%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Non-cardiac chest pain | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Pyrexia | 2/42 (4.8%) | 1/42 (2.4%) | 1/40 (2.5%) | 1/30 (3.3%) | 1/37 (2.7%) | 2/16 (12.5%) | 0/20 (0%) | 1/28 (3.6%) | 2/29 (6.9%) | 2/20 (10%) | 1/28 (3.6%) | |||||||||||
| Adverse drug reaction | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Feeling cold | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Oedema peripheral | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Thirst | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Temperature intolerance | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Immune system disorders | ||||||||||||||||||||||
| Hypersensitivity | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Infections and infestations | ||||||||||||||||||||||
| Asymptomatic bacteriuria | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 1/16 (6.3%) | 0/20 (0%) | 4/28 (14.3%) | 2/29 (6.9%) | 3/20 (15%) | 0/28 (0%) | |||||||||||
| Bacteriuria | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Conjunctivitis bacterial | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Escherichia urinary tract infection | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Gastroenteritis | 1/42 (2.4%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 2/37 (5.4%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Gastroenteritis viral | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Hand-foot-and-mouth disease | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Impetigo | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Infection parasitic | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Influenza | 4/42 (9.5%) | 1/42 (2.4%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Mastitis | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Nasopharyngitis | 5/42 (11.9%) | 1/42 (2.4%) | 2/40 (5%) | 1/30 (3.3%) | 2/37 (5.4%) | 1/16 (6.3%) | 2/20 (10%) | 3/28 (10.7%) | 3/29 (10.3%) | 2/20 (10%) | 1/28 (3.6%) | |||||||||||
| Oral herpes | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Pharyngitis | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 1/20 (5%) | 1/28 (3.6%) | |||||||||||
| Pyelonephritis | 0/42 (0%) | 0/42 (0%) | 2/40 (5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Rhinitis | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Sinusitis | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Tonsillitis | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Upper respiratory tract infection | 1/42 (2.4%) | 1/42 (2.4%) | 1/40 (2.5%) | 0/30 (0%) | 1/37 (2.7%) | 1/16 (6.3%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 1/20 (5%) | 2/28 (7.1%) | |||||||||||
| Urinary tract infection | 3/42 (7.1%) | 1/42 (2.4%) | 3/40 (7.5%) | 0/30 (0%) | 1/37 (2.7%) | 2/16 (12.5%) | 0/20 (0%) | 2/28 (7.1%) | 3/29 (10.3%) | 1/20 (5%) | 4/28 (14.3%) | |||||||||||
| Varicella | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Viral upper respiratory tract infection | 4/42 (9.5%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dermatitis infected | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Ear lobe infection | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Bronchitis | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Cellulitis | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Conjunctivitis | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Cystitis | 1/42 (2.4%) | 1/42 (2.4%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Cystitis bacterial | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Device related infection | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Ear infection | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Folliculitis | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Fungal skin infection | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Hordeolum | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Paronychia | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Pharyngotonsillitis | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Scrotal infection | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Eye infection | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||
| Skin laceration | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Contusion | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Investigations | ||||||||||||||||||||||
| Bacterial test positive | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Blood glucose decreased | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Eosinophil count increased | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Heart rate increased | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Investigation abnormal | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Residual urine volume increased | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Urine analysis abnormal | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Weight increased | 2/42 (4.8%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Urine output increased | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| White blood cells urine positive | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Cystogram | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||||
| Decreased appetite | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 1/20 (5%) | 1/28 (3.6%) | |||||||||||
| Dehydration | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Polydipsia | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||
| Arthralgia | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Pain in extremity | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Spinal deformity | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Synovitis | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Arthritis | 1/42 (2.4%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Joint contracture | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Muscular weakness | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Neck pain | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||
| Skin papilloma | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Nervous system disorders | ||||||||||||||||||||||
| Dizziness | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 2/28 (7.1%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Headache | 2/42 (4.8%) | 3/42 (7.1%) | 5/40 (12.5%) | 1/30 (3.3%) | 3/37 (8.1%) | 1/16 (6.3%) | 1/20 (5%) | 0/28 (0%) | 2/29 (6.9%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Peripheral sensory neuropathy | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Cognitive disorder | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Syncope | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Psychiatric disorders | ||||||||||||||||||||||
| Aggression | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 1/16 (6.3%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Anxiety | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Behaviour disorder | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Encopresis | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Restlessness | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Renal and urinary disorders | ||||||||||||||||||||||
| Haematuria | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Hypertonic bladder | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Incontinence | 0/42 (0%) | 2/42 (4.8%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Pollakiuria | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 1/16 (6.3%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Renal failure | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Urinary incontinence | 1/42 (2.4%) | 0/42 (0%) | 4/40 (10%) | 0/30 (0%) | 0/37 (0%) | 1/16 (6.3%) | 0/20 (0%) | 0/28 (0%) | 2/29 (6.9%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Urine odour abnormal | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 2/20 (10%) | 0/28 (0%) | |||||||||||
| Urethral pain | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Urinary tract disorder | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Urine flow decreased | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||||
| Genital pain | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Menstruation irregular | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||
| Asthma | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Cough | 0/42 (0%) | 2/42 (4.8%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dyspnoea | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Epistaxis | 0/42 (0%) | 1/42 (2.4%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 1/20 (5%) | 0/28 (0%) | 2/29 (6.9%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Nasal obstruction | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Oropharyngeal pain | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 1/30 (3.3%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Upper respiratory tract inflammation | 1/42 (2.4%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 1/28 (3.6%) | |||||||||||
| Respiratory disorder | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dry throat | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Rhinitis allergic | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Rhinorrhoea | 0/42 (0%) | 1/42 (2.4%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Nasal congestion | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||
| Acne | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Decubitus ulcer | 2/42 (4.8%) | 1/42 (2.4%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dermal cyst | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dermatitis acneiform | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dermatitis atopic | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Eczema | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 1/28 (3.6%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Pruritus | 1/42 (2.4%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Seborrhoeic dermatitis | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 1/20 (5%) | 0/28 (0%) | |||||||||||
| Skin odour abnormal | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 1/29 (3.4%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Urticaria | 0/42 (0%) | 0/42 (0%) | 1/40 (2.5%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Dermatitis allergic | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Rash macular | 1/42 (2.4%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Rash | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 0/30 (0%) | 1/37 (2.7%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Social circumstances | ||||||||||||||||||||||
| Wheelchair user | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
| Vascular disorders | ||||||||||||||||||||||
| Flushing | 0/42 (0%) | 0/42 (0%) | 0/40 (0%) | 1/30 (3.3%) | 0/37 (0%) | 0/16 (0%) | 0/20 (0%) | 0/28 (0%) | 0/29 (0%) | 0/20 (0%) | 0/28 (0%) | |||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01557244
Other Study ID Numbers:
- A0221047
- 2010-022475-55
First Posted:
Mar 19, 2012
Last Update Posted:
Feb 2, 2021
Last Verified:
Dec 1, 2020