SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00367835
Collaborator
(none)
217
34
2
13
6.4
0.5
Study Details
Study Description
Brief Summary
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
217 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder
Actual Study Start Date
:
Dec 4, 2006
Actual Primary Completion Date
:
Jan 4, 2008
Actual Study Completion Date
:
Jan 4, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SPD503 (Guanfacine hydrochloride)
|
Drug: SPD503 (Guanfacine hydrochloride)
Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks [Baseline and up to 8 weeks]
The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.
Secondary Outcome Measures
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks [Baseline and up to 8 weeks]
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
- Assessment of Clinical Global Impression-Severity of Illness (CGI-S) [up to 8 weeks]
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) [up to 8 weeks]
CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
- Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks [Baseline and up to 8 weeks]
Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity.
- Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks [Baseline and up to 8 weeks]
The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents.
- Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS) [up to 8 weeks]
The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of "strongly agree" or "agree".
- Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks [Baseline and up to 8 weeks]
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
- Change From Baseline in Pulse Rate at Up to 8 Weeks [Baseline and up to 8 weeks]
- Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks [Baseline and up to 8 weeks]
- Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks [Baseline and up to 8 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Healthy subjects with ADHD and oppositional symptoms
-
ADHD-RS>=24
-
CGI >=4
-
T-score of Opp subscale CPRS-R:L >=65
-
Normal ECG and BP
-
= 55 lbs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HOPE Research Institute | Phoenix | Arizona | United States | 85050 |
| 2 | Valley Clinical Research | El Centro | California | United States | 92243 |
| 3 | Peninsula Research Associates Inc | Rolling Hills Estates | California | United States | 90274 |
| 4 | Sarkis Clinical Trials | Gainesville | Florida | United States | 32607 |
| 5 | University of Florida | Gainesville | Florida | United States | 32610 |
| 6 | Amedica Research Institute, Inc | Hialeah | Florida | United States | 33013 |
| 7 | CORE Research, Inc | Maitland | Florida | United States | 32751 |
| 8 | Miami Research Associates | Miami | Florida | United States | 33143 |
| 9 | Clinical Neuroscience Solutions, Inc | Orlando | Florida | United States | 32806 |
| 10 | Childrens Developmental Center | Winter Park | Florida | United States | 32792 |
| 11 | Capstone Clinical Research | Libertyville | Illinois | United States | 60048 |
| 12 | Vince and Associates Clinical Research | Overland Park | Kansas | United States | 66212 |
| 13 | Pedia Research | Owensboro | Kentucky | United States | 42301 |
| 14 | Four Rivers Clinical Research | Paducah | Kentucky | United States | 42003 |
| 15 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 16 | CRI Worldwide, LLC | Clementon | New Jersey | United States | 08021 |
| 17 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
| 18 | University of Rochester, School of Medicine and Dentistry | Rochester | New York | United States | 14618 |
| 19 | SUNY Upsate Medical University | Syracuse | New York | United States | 13210 |
| 20 | Piedmont Neuropsychiatry | Charlotte | North Carolina | United States | 28226 |
| 21 | Duke Child & Family Study Center | Durham | North Carolina | United States | 27705 |
| 22 | University of Cincinnati | Cincinnati | Ohio | United States | 45267 |
| 23 | Discovery and Wellness Center for Children | Cleveland | Ohio | United States | 44106 |
| 24 | BHI Inc | Moore | Oklahoma | United States | 73160 |
| 25 | IPS Research Company | Oklahoma City | Oklahoma | United States | 73103 |
| 26 | Oregon Center for Clinical Investigations, Inc | Portland | Oregon | United States | 97210 |
| 27 | Oregon Center for Clinical Investigations, Inc | Salem | Oregon | United States | 97301 |
| 28 | CRI Worldwide, LLC | Philadelphia | Pennsylvania | United States | 19149 |
| 29 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
| 30 | Claghorn-Lesem Research Clinic Inc | Houston | Texas | United States | 77008 |
| 31 | Red Oak Psychiatry Associates, PA | Houston | Texas | United States | 77090 |
| 32 | NeuroScience, Inc | Herndon | Virginia | United States | 20170 |
| 33 | Dominion Clinical Research | Midlothian | Virginia | United States | 23112 |
| 34 | Eastside Therapeutic Resource | Kirkland | Washington | United States | 98033 |
Sponsors and Collaborators
- Shire
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Shire
ClinicalTrials.gov Identifier:
NCT00367835
Other Study ID Numbers:
- SPD503-307
First Posted:
Aug 23, 2006
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 217 subjects were randomized (138 to SPD503 and 79 to placebo). However, only 214 subjects received at least one dose of study medication (136 for SPD503 and 78 for placebo). Therefore, 214 subjects constitute the safety population. |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Period Title: Overall Study | ||
| STARTED | 138 | 79 |
| COMPLETED | 109 | 48 |
| NOT COMPLETED | 29 | 31 |
Baseline Characteristics
| Arm/Group Title | SPD503 | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | Total of all reporting groups | |
| Overall Participants | 138 | 79 | 217 |
| Age (Count of Participants) | |||
| <=18 years |
138
100%
|
79
100%
|
217
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
9.4
(1.73)
|
9.3
(2.04)
|
9.4
(1.84)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
50
36.2%
|
19
24.1%
|
69
31.8%
|
| Male |
88
63.8%
|
60
75.9%
|
148
68.2%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
138
100%
|
79
100%
|
217
100%
|
Outcome Measures
| Title | Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks |
|---|---|
| Description | The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms. |
| Time Frame | Baseline and up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of any investigational product during this study and with a baseline and at least one post-baseline efficacy measurement. |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 130 | 75 |
| Mean (Standard Deviation) [Units on a scale] |
-10.8
(7.23)
|
-7.0
(7.63)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SPD503, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks |
|---|---|
| Description | The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. |
| Time Frame | Baseline and up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 130 | 75 |
| Mean (Standard Deviation) [Units on a scale] |
-23.8
(14.43)
|
-11.4
(12.65)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SPD503, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) |
|---|---|
| Description | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) |
| Time Frame | up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 130 | 75 |
| 1 (Normal, not at all ill) |
25
18.1%
|
3
3.8%
|
| 2 (Borderline mentally ill) |
33
23.9%
|
6
7.6%
|
| 3 (Mildly ill) |
29
21%
|
15
19%
|
| 4 (Moderately ill) |
26
18.8%
|
24
30.4%
|
| 5 (Markedly ill) |
13
9.4%
|
22
27.8%
|
| 6 (Severely ill) |
4
2.9%
|
5
6.3%
|
| 7 (Among the most extremely ill) |
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SPD503, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) |
|---|---|
| Description | CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. |
| Time Frame | up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 130 | 75 |
| Number [Participants] |
93
67.4%
|
24
30.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SPD503, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks |
|---|---|
| Description | Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity. |
| Time Frame | Baseline and up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 130 | 75 |
| Mean (Standard Deviation) [units on a scale] |
-15.6
(12.86)
|
-10.3
(13.25)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SPD503, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks |
|---|---|
| Description | The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents. |
| Time Frame | Baseline and up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 109 | 57 |
| Mean (Standard Deviation) [Units on a scale] |
17.3
(19.76)
|
7.2
(18.29)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SPD503, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS) |
|---|---|
| Description | The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of "strongly agree" or "agree". |
| Time Frame | up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 129 | 69 |
| Number [Participants] |
84
60.9%
|
21
26.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SPD503, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks |
|---|---|
| Description | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. |
| Time Frame | Baseline and up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population defined as all randomized subjects who received at least one dose of any investigational product during this study. |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 107 | 58 |
| Mean (Standard Deviation) [msec] |
5.2
(15.74)
|
2.1
(17.41)
|
| Title | Change From Baseline in Pulse Rate at Up to 8 Weeks |
|---|---|
| Description | |
| Time Frame | Baseline and up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 130 | 75 |
| Mean (Standard Deviation) [beats/min] |
-4.3
(11.89)
|
0.7
(11.44)
|
| Title | Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks |
|---|---|
| Description | |
| Time Frame | Baseline and up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 130 | 75 |
| Mean (Standard Deviation) [mmHg] |
-2.6
(10.27)
|
0.7
(8.18)
|
| Title | Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks |
|---|---|
| Description | |
| Time Frame | Baseline and up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | SPD503 | Placebo |
|---|---|---|
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |
| Measure Participants | 130 | 75 |
| Mean (Standard Deviation) [mmHg] |
-1.3
(8.48)
|
0.9
(7.38)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | SPD503 | Placebo | ||
| Arm/Group Description | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | |||
All Cause Mortality |
||||
| SPD503 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| SPD503 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/136 (0%) | 0/78 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| SPD503 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 115/136 (84.6%) | 47/78 (60.3%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain upper | 16/136 (11.8%) | 2/78 (2.6%) | ||
| Vomiting | 10/136 (7.4%) | 5/78 (6.4%) | ||
| Nausea | 4/136 (2.9%) | 5/78 (6.4%) | ||
| General disorders | ||||
| Fatigue | 15/136 (11%) | 4/78 (5.1%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 6/136 (4.4%) | 4/78 (5.1%) | ||
| Investigations | ||||
| Blood pressure diastolic decreased | 8/136 (5.9%) | 1/78 (1.3%) | ||
| Nervous system disorders | ||||
| Somnolence | 69/136 (50.7%) | 5/78 (6.4%) | ||
| Headache | 30/136 (22.1%) | 14/78 (17.9%) | ||
| Sedation | 18/136 (13.2%) | 1/78 (1.3%) | ||
| Dizziness | 7/136 (5.1%) | 3/78 (3.8%) | ||
| Psychiatric disorders | ||||
| Irritability | 11/136 (8.1%) | 2/78 (2.6%) | ||
| Affect lability | 2/136 (1.5%) | 4/78 (5.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pharyngolaryngeal pain | 5/136 (3.7%) | 4/78 (5.1%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Shire |
| Phone | +1 866 842 5335 |
| ClinicalTransparency@shire.com |
Responsible Party:
Shire
ClinicalTrials.gov Identifier:
NCT00367835
Other Study ID Numbers:
- SPD503-307
First Posted:
Aug 23, 2006
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021