Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 99 of 439 for:    Methylphenidate

The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00758160
Recruitment Status : Completed
First Posted : September 23, 2008
Results First Posted : April 8, 2014
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Disorder With Hyperactivity
Intervention Drug: OROS Methylphenidate
Enrollment 296
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OROS MPH
Hide Arm/Group Description Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Period Title: Overall Study
Started 296
Completed 230
Not Completed 66
Reason Not Completed
No Longer Requires Study Medication             4
Administration Problems             3
Adverse Event             15
Lack of Efficacy             10
Lost to Follow-up             14
Protocol Violation             12
Withdrawal by Subject             8
Arm/Group Title OROS MPH
Hide Arm/Group Description Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Baseline Participants 296
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 296 participants
9.5  (2.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants
Female
49
  16.6%
Male
247
  83.4%
1.Primary Outcome
Title Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Hide Description Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Inattention (n = 293) 1.7  (0.6)
Baseline: Hyperactivity (n = 293) 1.4  (0.7)
Baseline: Oppositional (n = 296) 1.3  (0.7)
Change at Week 2: Inattention (n = 293) -0.4  (0.5)
Change at Week 2: Hyperactivity (n = 293) -0.3  (0.5)
Change at Week 2: Oppositional (n = 296) -0.3  (0.5)
2.Primary Outcome
Title Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
Hide Description Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 4: Inattention (n = 293) -0.4  (0.6)
Change at Week 4: Hyperactivity (n = 293) -0.3  (0.6)
Change at Week 4: Oppositional (n = 296) -0.3  (0.6)
3.Primary Outcome
Title Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
Hide Description Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 8: Inattention (n = 293) -0.5  (0.6)
Change at Week 8: Hyperactivity (n = 293) -0.4  (0.6)
Change at Week 8: Oppositional (n = 296) -0.4  (0.6)
4.Primary Outcome
Title Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
Hide Description The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 275
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Mother Assessment (n = 275) 1.9  (0.6)
Baseline: Father Assessment (n = 216) 1.7  (0.4)
Change at Week 4: Mother Assessment (n = 275) -0.1  (0.4)
Change at Week 4: Father Assessment (n = 216) 0  (0.3)
5.Primary Outcome
Title Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8
Hide Description The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 275
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 8: Mother Assessment (n = 275) -0.1  (0.4)
Change at Week 8: Father Assessment (n = 216) 0  (0.4)
6.Secondary Outcome
Title Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Hide Description Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.
Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 281
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Mother Assessment (n = 275) 6.4  (2.9)
Baseline: Father Assessment (n = 216) 6.5  (2.5)
Week 4: Mother Assessment (n = 280) 6.6  (2.8)
Week 4: Father Assessment (n = 223) 6.7  (2.5)
Week 8: Mother Assessment (n = 281) 6.5  (3)
Week 8: Father Assessment (n = 226) 6.6  (2.7)
7.Secondary Outcome
Title Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Hide Description Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.
Time Frame Baseline, Week 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 288
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Inattention (n = 281) 1.5  (0.7)
Baseline:Hyperactivity (n = 285) 1.1  (0.7)
Baseline: Oppositional (n = 283) 0.9  (0.7)
Week 2: Inattention (n = 286) 1.3  (0.7)
Week 2: Hyperactivity (n = 287) 0.9  (0.7)
Week 2: Oppositional (n = 286) 0.7  (0.7)
Week 4: Inattention (n = 287) 1.2  (0.6)
Week 4: Hyperactivity (n = 288) 0.9  (0.8)
Week 4: Oppositional (n = 287) 0.7  (0.7)
Week 8: Inattention (n = 287) 1.1  (0.6)
Week 8: Hyperactivity (n = 288) 0.8  (0.7)
Week 8: Oppositional (n = 287) 0.7  (0.7)
8.Secondary Outcome
Title Social Adjustment Scale Score for Children and Adolescents (SAICA)
Hide Description SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children’s current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.
Time Frame Baseline, Week 4 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 165
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n = 151) 1.5  (0.7)
Week 4 (n = 160) 1.8  (0.3)
Week 8 (n = 165) 1.8  (0.3)
9.Secondary Outcome
Title Clinical Global Impression-Severity (CGI-S) Score
Hide Description CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.
Time Frame Baseline, Week 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 292
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n = 290) 4.3  (0.9)
Week 2 (n = 291) 3.5  (1.0)
Week 4 (n = 291) 3.1  (1.1)
Week 8 (n = 292) 3.0  (1.1)
10.Secondary Outcome
Title Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Hide Description CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).
Time Frame Baseline, Week 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 292
Measure Type: Number
Unit of Measure: Participants
Week 2: Very much improved (n = 292) 4
Week 2: Much improved (n = 292) 98
Week 2: Minimally improved (n = 292) 126
Week 2: No change (n = 292) 45
Week 2: Minimally worse (n = 292) 16
Week 2: Much worse (n = 292) 2
Week 2: Very much worse (n = 292) 1
Week 4: Very much improved (n = 262) 15
Week 4: Much improved (n = 262) 111
Week 4: Minimally improved (n = 262) 96
Week 4: No change (n = 262) 27
Week 4: Minimally worse (n = 262) 10
Week 4: Much worse (n = 262) 3
Week 4: Very much worse (n = 262) 0
Week 8: Very much improved (n = 282) 16
Week 8: Much improved (n = 282) 129
Week 8: Minimally improved (n = 282) 91
Week 8: No change (n = 282) 28
Week 8: Minimally worse (n = 282) 13
Week 8: Much worse (n = 282) 4
Week 8: Very much worse (n = 282) 1
11.Secondary Outcome
Title Global Assessment of Satisfaction by Parents/Caregivers
Hide Description Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.
Time Frame Baseline, Week 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 291
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n = 290) 3.1  (0.9)
Week 2 (n = 291) 3.4  (0.8)
Week 4 (n = 291) 3.7  (0.8)
Week 8 (n = 291) 3.6  (0.9)
12.Other Pre-specified Outcome
Title Global Assessment of Satisfaction by Participant
Hide Description Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied.
Time Frame Baseline, Week 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
Arm/Group Title OROS MPH
Hide Arm/Group Description:
Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
Overall Number of Participants Analyzed 291
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n = 290) 3.2  (0.9)
Week 2 (n = 291) 3.5  (0.8)
Week 4 (n = 291) 3.7  (0.8)
Week 8 (n = 291) 3.6  (0.9)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled “Other” was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
 
Arm/Group Title OROS MPH-Baseline OROS MPH-Week 2 OROS MPH-Week 4 OROS MPH-Week 8
Hide Arm/Group Description Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
All-Cause Mortality
OROS MPH-Baseline OROS MPH-Week 2 OROS MPH-Week 4 OROS MPH-Week 8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OROS MPH-Baseline OROS MPH-Week 2 OROS MPH-Week 4 OROS MPH-Week 8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/296 (0.00%)   0/296 (0.00%)   0/296 (0.00%)   0/296 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
OROS MPH-Baseline OROS MPH-Week 2 OROS MPH-Week 4 OROS MPH-Week 8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   80/296 (27.03%)   100/296 (33.78%)   90/296 (30.41%)   95/296 (32.09%) 
General disorders         
Appetite decreased * 1  80/296 (27.03%)  100/296 (33.78%)  90/296 (30.41%)  95/296 (32.09%) 
Nausea * 1  22/296 (7.43%)  22/296 (7.43%)  15/296 (5.07%)  15/296 (5.07%) 
Insomnia * 1  22/296 (7.43%)  35/296 (11.82%)  30/296 (10.14%)  25/296 (8.45%) 
Headache * 1  17/296 (5.74%)  14/296 (4.73%)  8/296 (2.70%)  7/296 (2.36%) 
Dizziness * 1  12/296 (4.05%)  10/296 (3.38%)  6/296 (2.03%)  9/296 (3.04%) 
Somnolence * 1  8/296 (2.70%)  4/296 (1.35%)  2/296 (0.68%)  1/296 (0.34%) 
Abdominal pain * 1  17/296 (5.74%)  20/296 (6.76%)  11/296 (3.72%)  12/296 (4.05%) 
Stomachache * 1  5/296 (1.69%)  4/296 (1.35%)  1/296 (0.34%)  1/296 (0.34%) 
Other * 2  26/296 (8.78%)  32/296 (10.81%)  25/296 (8.45%)  24/296 (8.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, No dictionary used
2
Term from vocabulary, Other
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs Director
Organization: Janssen Pharmaceutical, Taiwan
Phone: +886-2-23762155
Layout table for additonal information
Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00758160     History of Changes
Other Study ID Numbers: CR015331
CONCERTAATT4086
CCT-TWN-MA6
First Submitted: September 19, 2008
First Posted: September 23, 2008
Results First Submitted: September 5, 2013
Results First Posted: April 8, 2014
Last Update Posted: April 8, 2014