Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00448916
Collaborator
(none)
54
18
1
77
3
0
Study Details
Study Description
Brief Summary
The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
54 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 12-month Open-label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures
Study Start Date
:
May 1, 2007
Actual Primary Completion Date
:
Oct 1, 2013
Actual Study Completion Date
:
Oct 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pregabalin Orally-administered pregabalin |
Drug: Pregabalin
Orally-administered pregabalin
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events (AE). [12 Months]
An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.
Secondary Outcome Measures
- Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. [Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.]
Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as "abnormal" and no abnormalities in the sites were reported as "normal". Any change from the previous physical examination results were noted.
- Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. [Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up]
Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined.
- Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months). [Visit 1 to 12 Months]
Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below.
- Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months). [Visit 1 to 12 Months]
Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below.
- Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months). [Visit 1 to 12 Months]
Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below.
- Derived Body Mass Index Data (BMI) at Month 12/Early Termination. [Month 12/Early Termination]
BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.
- Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up. [Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up]
Weight was recorded in kilograms and weight change from Baseline was reported.
- Height at Month 12/Early Termination. [Month 12/Early Termination]
Height was recorded in centimeters.
- Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months). [Week 1 to 12 Months]
Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated. Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below.
- Number of Participants With Hematotolgical Abnormalities. [12 Months]
Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN.
- Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy). [12 Months]
Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted.
- Number of Participants With Abnormalities in Endocrine Panel (Hormones). [12 Months]
Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN.
- Number of Participants With Abnormalities in Creatine Kinase. [12 Months]
Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted.
- Seizure Frequency. [28 Days]
Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE.
- Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein). [12 Months]
Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Month
to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Partial onset seizures, incompletely controlled on 1-3 medications
-
At least 1 seizure per 28 days, on average
-
Completion of study A0081074
Exclusion Criteria:
-
Primary generalized seizures
-
Progressive CNS pathology
-
Failure to tolerate pregabalin in study A0081074
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Alabama | Mobile | Alabama | United States | 36604 |
| 2 | University of South Alabama Department of Neurology | Mobile | Alabama | United States | 36693 |
| 3 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016 |
| 4 | The Children's Clinica of Jonesboro, P.A | Jonesboro | Arkansas | United States | 72401 |
| 5 | Clinical Study Centers, L. L. C. | Little Rock | Arkansas | United States | 72205 |
| 6 | UCSF Neurology Clinic | San Francisco | California | United States | 94143 |
| 7 | Child Neurology Center of Northwest Florida | Gulf Breeze | Florida | United States | 32561 |
| 8 | The Office of Sergio J Jacinto, MD | Tampa | Florida | United States | 33603 |
| 9 | Pediatric Epilepsy & Neurology Specialists | Tampa | Florida | United States | 33609 |
| 10 | St. John's Clinic | Springfield | Missouri | United States | 65804 |
| 11 | St. John's Hospital | Springfield | Missouri | United States | 65804 |
| 12 | Women and Children's Hospital of Buffalo | Buffalo | New York | United States | 14222 |
| 13 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 14 | Baylor College of Medicine - Texas Children's Hospital | Houston | Texas | United States | 77030 |
| 15 | Texas Children's Hospital | Houston | Texas | United States | 77030 |
| 16 | Road Runner Research, Ltd. | San Antonio | Texas | United States | 78258 |
| 17 | Yonsei University College of Medicine Severance Hospital / Department of Pediatric Neurology | Seoul | Korea, Republic of | 120-752 | |
| 18 | Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Jalisco | Mexico | 44280 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00448916
Other Study ID Numbers:
- A0081075
- 2010-020731-39
First Posted:
Mar 19, 2007
Last Update Posted:
Jan 25, 2021
Last Verified:
Nov 1, 2014
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This study was a dose extension study of pediatric participants with refractory partial-onset seizures who had completed study A0081074 (NCT00437281). Participants were enrolled in 3 countries at 13 study centers with 13 investigators: Republic of Korea (1 center), Mexico (1 center), and the United States (11 centers). |
|---|---|
| Pre-assignment Detail | Each participant was restricted to the dose levels that they had previously tolerated, or that had shown acceptable safety and tolerability in study A0081074 (NCT00437281) for the participant's age group. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
| Period Title: Overall Study | ||||
| STARTED | 16 | 15 | 12 | 11 |
| COMPLETED | 9 | 9 | 6 | 5 |
| NOT COMPLETED | 7 | 6 | 6 | 6 |
Baseline Characteristics
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Total of all reporting groups |
| Overall Participants | 16 | 15 | 12 | 11 | 54 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
1.18
(0.57)
|
4.14
(1.23)
|
9.98
(1.30)
|
14.86
(1.53)
|
6.74
(5.35)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
8
50%
|
9
60%
|
5
41.7%
|
3
27.3%
|
25
46.3%
|
| Male |
8
50%
|
6
40%
|
7
58.3%
|
8
72.7%
|
29
53.7%
|
Outcome Measures
| Title | Number of Participants With Adverse Events (AE). |
|---|---|
| Description | An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
| Measure Participants | 16 | 15 | 12 | 11 |
| Participants with AEs |
14
87.5%
|
13
86.7%
|
11
91.7%
|
9
81.8%
|
| Participants with serious AEs |
8
50%
|
3
20%
|
0
0%
|
1
9.1%
|
| Participants with severe AEs |
7
43.8%
|
4
26.7%
|
0
0%
|
1
9.1%
|
| Title | Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. |
|---|---|
| Description | Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as "abnormal" and no abnormalities in the sites were reported as "normal". Any change from the previous physical examination results were noted. |
| Time Frame | Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
| Measure Participants | 16 | 15 | 12 | 11 |
| Week 1 (N=16,13,11,10) |
2
12.5%
|
1
6.7%
|
0
0%
|
0
0%
|
| Month 1 (N=14,13,10,10) |
1
6.3%
|
1
6.7%
|
0
0%
|
0
0%
|
| Month 6 (N=11,10,6,7) |
1
6.3%
|
1
6.7%
|
0
0%
|
0
0%
|
| Month 12/Eary Termination (N=16,12,12,9) |
1
6.3%
|
2
13.3%
|
1
8.3%
|
1
9.1%
|
| Follow-up (N=6,4,9,6) |
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
| Title | Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. |
|---|---|
| Description | Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined. |
| Time Frame | Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 16 | 15 | 12 | 11 |
| Week 1 (N=16,13,11,10) |
1
6.3%
|
0
0%
|
0
0%
|
0
0%
|
| Month 1 (N=14,13,10,10) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Month 6 (N=11,10,6,7) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Month 12/Early Termination (N=16,11,12,9) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Follow-up (N=6,4,9,6) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months). |
|---|---|
| Description | Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below. |
| Time Frame | Visit 1 to 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 16 | 15 | 12 | 11 |
| ≥ 20% increase from Baseline |
12
75%
|
5
33.3%
|
8
66.7%
|
3
27.3%
|
| ≥ 20% decrease from Baseline |
5
31.3%
|
7
46.7%
|
3
25%
|
3
27.3%
|
| > 1.25 * ULN |
1
6.3%
|
1
6.7%
|
0
0%
|
0
0%
|
| < 0.9 * LLN |
0
0%
|
0
0%
|
3
25%
|
0
0%
|
| Title | Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months). |
|---|---|
| Description | Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below. |
| Time Frame | Visit 1 to 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 16 | 15 | 12 | 11 |
| ≥ 30% increase from Baseline |
2
12.5%
|
3
20%
|
1
8.3%
|
1
9.1%
|
| ≥ 30% decrease from Baseline |
2
12.5%
|
1
6.7%
|
0
0%
|
0
0%
|
| > 1.25 * ULN |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| < 0.9 * LLN |
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
| Title | Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months). |
|---|---|
| Description | Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below. |
| Time Frame | Visit 1 to 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 16 | 15 | 12 | 11 |
| > 1.5 * ULN |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| < 0.9 * LLN |
5
31.3%
|
2
13.3%
|
1
8.3%
|
0
0%
|
| Title | Derived Body Mass Index Data (BMI) at Month 12/Early Termination. |
|---|---|
| Description | BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2. |
| Time Frame | Month 12/Early Termination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. Data was available for 15, 11, 10 and 7 participants in Pregabalin 1-23 months group, 2-6 years group, 7-11 years group and 12-16 years group respectively. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 15 | 11 | 10 | 7 |
| Mean (Standard Deviation) [Kg/m^2] |
16.2
(1.73)
|
18.0
(3.52)
|
20.6
(6.52)
|
24.8
(7.72)
|
| Title | Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up. |
|---|---|
| Description | Weight was recorded in kilograms and weight change from Baseline was reported. |
| Time Frame | Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 16 | 15 | 12 | 11 |
| Day 9 (N=16,14,12,11) |
0.1
(0.16)
|
0.1
(0.29)
|
-0.1
(0.79)
|
0.4
(1.07)
|
| Week 1 (N=16,13,11,10) |
0.3
(0.29)
|
0.4
(0.61)
|
1.5
(1.15)
|
1.2
(1.43)
|
| Month 1 (N=14,13,10,10) |
0.4
(0.45)
|
0.8
(0.73)
|
2.1
(1.77)
|
2.4
(1.52)
|
| Month 2 (N=11,12,8,9) |
1.0
(0.73)
|
1.2
(1.12)
|
3.8
(3.25)
|
3.0
(1.81)
|
| Month 4 (N=11,10,7,9) |
1.3
(0.86)
|
1.3
(1.29)
|
5.2
(4.32)
|
4.1
(2.28)
|
| Month 6 (N=11,10,6,7) |
1.8
(0.98)
|
1.4
(1.52)
|
5.9
(4.17)
|
5.9
(3.32)
|
| Month 9 (N=9,10,6,5) |
2.4
(1.18)
|
2.3
(2.52)
|
6.3
(4.66)
|
7.3
(4.32)
|
| Month 12/Early Termination (N=15,12,11,8) |
1.8
(1.33)
|
2.4
(2.71)
|
6.0
(4.78)
|
6.6
(4.51)
|
| Title | Height at Month 12/Early Termination. |
|---|---|
| Description | Height was recorded in centimeters. |
| Time Frame | Month 12/Early Termination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 15 | 11 | 10 | 7 |
| Mean (Standard Deviation) [cm] |
83.3
(8.87)
|
109.9
(12.76)
|
145.6
(13.21)
|
167.3
(8.18)
|
| Title | Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months). |
|---|---|
| Description | Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated. Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below. |
| Time Frame | Week 1 to 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 16 | 15 | 12 | 11 |
| PR interval: ≥ 200 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PR interval: ≥50% increase from Baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PR interval: ≥25% increase from Baseline |
1
6.3%
|
0
0%
|
1
8.3%
|
0
0%
|
| QRS interval: ≥ 200 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| QRS interval: ≥25% increase from Baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| QT interval: ≥ 500 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| QTcB interval: 450-<480 msec |
1
6.3%
|
1
6.7%
|
1
8.3%
|
2
18.2%
|
| QTcB interval: 480-<500 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| QTcB interval: ≥ 500 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| QTcF interval: 450-<480 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| QTcF interval: 480-<500 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| QTcF interval: ≥ 500 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Hematotolgical Abnormalities. |
|---|---|
| Description | Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 16 | 15 | 12 | 11 |
| Platelets: <0.5xLLN (N=16,15,12,11) |
1
6.3%
|
1
6.7%
|
0
0%
|
0
0%
|
| Platelets: >1.75xULN (N=16,15,12,11) |
1
6.3%
|
0
0%
|
0
0%
|
0
0%
|
| WBC count: <0.6xLLN (N=15,15,12,11) |
1
6.3%
|
2
13.3%
|
0
0%
|
0
0%
|
| WBC count: >1.5xULN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Lymphocytes-Abs: <0.8xLLN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Lymphocytes-Abs: >1.2xULN (N=15,15,12,11) |
1
6.3%
|
0
0%
|
0
0%
|
2
18.2%
|
| Total neutrophils-Abs: <0.8xLLN (N=15,15,12,11) |
3
18.8%
|
4
26.7%
|
3
25%
|
3
27.3%
|
| Total neutrophils-Abs: >1.2xULN (N=15,15,12,11) |
1
6.3%
|
1
6.7%
|
0
0%
|
0
0%
|
| Eosinophils-Abs: >1.2xULN (N=15,15,12,11) |
3
18.8%
|
1
6.7%
|
1
8.3%
|
0
0%
|
| Hemoglobin: <0.8xLLN(N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hematocrit: <0.8xLLN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Red blood cell count: <0.8xLLN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Basophils: >1.2xULN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Monocytes: >1.2xULN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy). |
|---|---|
| Description | Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 11 | 15 | 11 | 11 |
| Number [Participants] |
1
6.3%
|
1
6.7%
|
0
0%
|
1
9.1%
|
| Title | Number of Participants With Abnormalities in Endocrine Panel (Hormones). |
|---|---|
| Description | Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 16 | 15 | 12 | 11 |
| T4 (free): <0.8xLLN (N=13,13,11,10) |
0
0%
|
1
6.7%
|
0
0%
|
0
0%
|
| T4 (free): >1.2xULN (N=13,13,11,10) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| TSH: <0.8xLLN (N=14,12,11,10) |
1
6.3%
|
0
0%
|
0
0%
|
0
0%
|
| TSH: >1.2xULN (N=14,12,11,10) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Abnormalities in Creatine Kinase. |
|---|---|
| Description | Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 15 | 15 | 12 | 11 |
| Number [Participants] |
0
0%
|
1
6.7%
|
1
8.3%
|
4
36.4%
|
| Title | Seizure Frequency. |
|---|---|
| Description | Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE. |
| Time Frame | 28 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
| Measure Participants | 16 | 15 | 12 | 11 |
| Number [Participants] |
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Title | Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein). |
|---|---|
| Description | Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one dose of study medication were included. |
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
| Measure Participants | 15 | 15 | 12 | 11 |
| Alanine Aminotransferase: >3.0xULN (N=15,15,12,11) |
0
0%
|
1
6.7%
|
1
8.3%
|
0
0%
|
| Blood Urea Nitrogen: >1.3xULN |
2
12.5%
|
5
33.3%
|
1
8.3%
|
0
0%
|
| Albumin: <0.8xLLN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Albumin: >1.2xULN (N=15,15,12,11) |
2
12.5%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium: <0.9xLLN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium: >1.1xULN (N=15,15,12,11) |
1
6.3%
|
0
0%
|
1
8.3%
|
0
0%
|
| Magnesium: <0.9xLLN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Magnesium: >1.1xULN (N=15,15,12,11) |
1
6.3%
|
2
13.3%
|
0
0%
|
1
9.1%
|
| Phosphate: <0.8xLLN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Phosphate: >1.2xULN (N=15,15,12,11) |
0
0%
|
1
6.7%
|
1
8.3%
|
0
0%
|
| Bicarbonate (venous): <0.9xLLN (N=15,15,12,11) |
9
56.3%
|
11
73.3%
|
7
58.3%
|
3
27.3%
|
| Bicarbonate (venous): >1.1xULN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Glucose: <0.6xLLN (N=15,15,12,11) |
1
6.3%
|
1
6.7%
|
0
0%
|
0
0%
|
| Glucose: >1.5xULN (N=15,15,12,11) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Insulin-like GrowthFactor:<0.9xLLN(N=12,13,11,10) |
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
| Insulin-like GrowthFactor:>1.1xULN(N=12,13,11,10) |
5
31.3%
|
8
53.3%
|
4
33.3%
|
6
54.5%
|
| IGF Binding Protein: <0.9xLLN (N=12,13,11,10) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| IGF Binding Protein: >1.1xULN (N=12,13,11,10) |
4
25%
|
2
13.3%
|
5
41.7%
|
0
0%
|
| Lipid profile cholesterol/triglycerides(N=1,4,0,1) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | From Visit 1 to Visit 9 (Follow-up visit) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. | |||||||||
| Arm/Group Title | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years | Overall | |||||
| Arm/Group Description | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | This arm summarizes the AE data from all the treatment groups. | |||||
All Cause Mortality |
||||||||||
| Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years | Overall | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years | Overall | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/16 (50%) | 3/15 (20%) | 0/12 (0%) | 1/11 (9.1%) | 12/54 (22.2%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Thrombocytopenia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Gastrointestinal disorders | ||||||||||
| Gastritis | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Gastrooesophageal reflux disease | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Ileus | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Salivary hypersecretion | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Infections and infestations | ||||||||||
| Croup infectious | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Otitis media acute | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Pneumonia | 1/16 (6.3%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 2/54 (3.7%) | |||||
| Respiratory syncytial virus bronchiolitis | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Upper respiratory tract infection | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Nervous system disorders | ||||||||||
| Convulsion | 3/16 (18.8%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Status epilepticus | 1/16 (6.3%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 2/54 (3.7%) | |||||
| Unresponsive to stimuli | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Apnoea | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Bronchial hyperreactivity | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Respiratory distress | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Respiratory failure | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years | Overall | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/16 (87.5%) | 13/15 (86.7%) | 11/12 (91.7%) | 9/11 (81.8%) | 47/54 (87%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Cyclic neutropenia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Leukocytosis | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Neutropenia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Normochromic normocytic anaemia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Thrombocytosis | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Cardiac disorders | ||||||||||
| Bundle branch block left | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Congenital, familial and genetic disorders | ||||||||||
| Cryptorchism | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Ear pain | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 1/11 (9.1%) | 2/54 (3.7%) | |||||
| Eye disorders | ||||||||||
| Astigmatism | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Conjunctivitis | 1/16 (6.3%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 2/54 (3.7%) | |||||
| Excessive eye blinking | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Hypermetropia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal distension | 2/16 (12.5%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 2/54 (3.7%) | |||||
| Abdominal pain | 3/16 (18.8%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Abdominal tenderness | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Constipation | 5/16 (31.3%) | 1/15 (6.7%) | 1/12 (8.3%) | 0/11 (0%) | 7/54 (13%) | |||||
| Diarrhoea | 3/16 (18.8%) | 3/15 (20%) | 0/12 (0%) | 0/11 (0%) | 6/54 (11.1%) | |||||
| Faeces pale | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Gastrooesophageal reflux disease | 3/16 (18.8%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Retching | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Salivary hypersecretion | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Tooth impacted | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Vomiting | 2/16 (12.5%) | 1/15 (6.7%) | 0/12 (0%) | 1/11 (9.1%) | 4/54 (7.4%) | |||||
| General disorders | ||||||||||
| Chest pain | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Crying | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Fatigue | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Irritability | 3/16 (18.8%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Pyrexia | 9/16 (56.3%) | 3/15 (20%) | 0/12 (0%) | 3/11 (27.3%) | 15/54 (27.8%) | |||||
| Thirst | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Infections and infestations | ||||||||||
| Bacterial sepsis | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Bronchitis | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Cystitis | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Device related infection | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Ear infection | 0/16 (0%) | 4/15 (26.7%) | 1/12 (8.3%) | 0/11 (0%) | 5/54 (9.3%) | |||||
| Eye infection | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Gastroenteritis | 1/16 (6.3%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 2/54 (3.7%) | |||||
| Hordeolum | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Nasopharyngitis | 3/16 (18.8%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Otitis media | 4/16 (25%) | 4/15 (26.7%) | 0/12 (0%) | 0/11 (0%) | 8/54 (14.8%) | |||||
| Otitis media acute | 2/16 (12.5%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Pharyngitis streptococcal | 0/16 (0%) | 2/15 (13.3%) | 1/12 (8.3%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Pharyngotonsillitis | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Pneumonia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Rhinitis | 2/16 (12.5%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Sinusitis | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Staphylococcal infection | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Tinea infection | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Upper respiratory tract infection | 3/16 (18.8%) | 5/15 (33.3%) | 2/12 (16.7%) | 0/11 (0%) | 10/54 (18.5%) | |||||
| Urinary tract infection | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Viral upper respiratory tract infection | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Anal injury | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Arthropod bite | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Arthropod sting | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Excoriation | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 2/11 (18.2%) | 2/54 (3.7%) | |||||
| Fall | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Foot fracture | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Laceration | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Anticonvulsant drug level increased | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Blood thyroid stimulating hormone decreased | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Neutrophil count decreased | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Weight increased | 0/16 (0%) | 1/15 (6.7%) | 1/12 (8.3%) | 0/11 (0%) | 2/54 (3.7%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 2/16 (12.5%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Hyperkalaemia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Increased appetite | 0/16 (0%) | 1/15 (6.7%) | 1/12 (8.3%) | 0/11 (0%) | 2/54 (3.7%) | |||||
| Metabolic acidosis | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Polydipsia | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Muscle twitching | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Musculoskeletal pain | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Nervous system disorders | ||||||||||
| Cognitive disorder | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Convulsion | 2/16 (12.5%) | 1/15 (6.7%) | 3/12 (25%) | 1/11 (9.1%) | 7/54 (13%) | |||||
| Dizziness | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 1/11 (9.1%) | 2/54 (3.7%) | |||||
| Headache | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Lethargy | 0/16 (0%) | 2/15 (13.3%) | 0/12 (0%) | 1/11 (9.1%) | 3/54 (5.6%) | |||||
| Partial seizures | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Somnolence | 2/16 (12.5%) | 0/15 (0%) | 1/12 (8.3%) | 1/11 (9.1%) | 4/54 (7.4%) | |||||
| Status epilepticus | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Psychiatric disorders | ||||||||||
| Aggression | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Anger | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Attention deficit/hyperactivity disorder | 0/16 (0%) | 1/15 (6.7%) | 1/12 (8.3%) | 0/11 (0%) | 2/54 (3.7%) | |||||
| Depression | 0/16 (0%) | 0/15 (0%) | 0/12 (0%) | 1/11 (9.1%) | 1/54 (1.9%) | |||||
| Dissociation | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Dysphemia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Dyssomnia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Hallucination, visual | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Insomnia | 1/16 (6.3%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 2/54 (3.7%) | |||||
| Personality change | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Restlessness | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Renal and urinary disorders | ||||||||||
| Proteinuria | 2/16 (12.5%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Urine odour abnormal | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Bronchospasm | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Cough | 4/16 (25%) | 2/15 (13.3%) | 0/12 (0%) | 0/11 (0%) | 6/54 (11.1%) | |||||
| Epistaxis | 0/16 (0%) | 2/15 (13.3%) | 1/12 (8.3%) | 1/11 (9.1%) | 4/54 (7.4%) | |||||
| Hypoxia | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Nasal congestion | 2/16 (12.5%) | 3/15 (20%) | 1/12 (8.3%) | 0/11 (0%) | 6/54 (11.1%) | |||||
| Productive cough | 2/16 (12.5%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Respiratory distress | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Rhinorrhoea | 1/16 (6.3%) | 2/15 (13.3%) | 0/12 (0%) | 0/11 (0%) | 3/54 (5.6%) | |||||
| Rhonchi | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Snoring | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Upper-airway cough syndrome | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Wheezing | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Dermatitis contact | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Dermatitis diaper | 3/16 (18.8%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 4/54 (7.4%) | |||||
| Pruritus | 0/16 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Rash | 0/16 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
| Surgical and medical procedures | ||||||||||
| Adenoidectomy | 1/16 (6.3%) | 0/15 (0%) | 0/12 (0%) | 0/11 (0%) | 1/54 (1.9%) | |||||
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's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00448916
Other Study ID Numbers:
- A0081075
- 2010-020731-39
First Posted:
Mar 19, 2007
Last Update Posted:
Jan 25, 2021
Last Verified:
Nov 1, 2014