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Trial record 34 of 439 for:    Methylphenidate

An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT01060150
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : July 31, 2013
Last Update Posted : August 23, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

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 HCl
Enrollment 115
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Period Title: Overall Study
Started 115
Treated 113
Completed 92
Not Completed 23
Reason Not Completed
Adverse Event             6
Lost to Follow-up             1
Protocol Violation             6
Withdrawal by Subject             8
Enrolled, but not treated             2
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Baseline Participants 113
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants
15.24  (1.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants
Female
27
  23.9%
Male
86
  76.1%
Korean Version of Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 113 participants
27.58  (8.92)
[1]
Measure Description: The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with higher score indicating more severity of the condition.
Clinical Global Impression - Severity (CGI-S) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 113 participants
4.88  (0.79)
[1]
Measure Description: The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Learning Skill Test (LST) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  T-score
Number Analyzed 113 participants
40.97  (11.07)
[1]
Measure Description: The LST measures learning ability of student. It is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student and 80 items for high school student. Each item is rated on 5-point Likert scale (1=never to 5=always). Total score range:70-350 (middle school) and 80-400 (high school). In result analysis, each sub-score and total score was converted to T-score for normalization. Score range of T-score: 1-100 with a mean of 50. Higher score indicates better ability for learning.
1.Primary Outcome
Title Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score
Hide Description The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using Last observation carried forward (LOCF).
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 113
Mean (Standard Deviation)
Unit of Measure: Units on a scale
11.78  (7.64)
2.Primary Outcome
Title Clinical Global Impression - Severity (CGI-S) Score
Hide Description The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using LOCF.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 113
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.81  (1.12)
3.Primary Outcome
Title Clinical Global Impression - Improvement (CGI-I) Score
Hide Description The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.14  (0.75)
4.Primary Outcome
Title Learning Skill Test (LST) Total Score
Hide Description The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 98
Mean (Standard Deviation)
Unit of Measure: T-score
49.61  (11.57)
5.Secondary Outcome
Title Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors
Hide Description The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 101
Mean (Standard Deviation)
Unit of Measure: Errors
Omission errors: Baseline 58.88  (27.35)
Omission errors: Week 12 57.40  (48.79)
Commission errors: Baseline 62.98  (32.32)
Commission errors: Week 12 51.70  (21.19)
6.Secondary Outcome
Title Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability
Hide Description The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor’s score is over 65 point, the participant is resulted in having attention deficit.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 101
Mean (Standard Deviation)
Unit of Measure: Units on scale
Reaction time average: Baseline 54.32  (15.45)
Reaction time average: Week 12 49.73  (26.33)
Response variability: Baseline 85.77  (60.21)
Response variability: Week 12 59.42  (64.77)
7.Secondary Outcome
Title Digit Span Test Score
Hide Description Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Forward: Baseline 11.19  (2.92)
Forward: Week 12 11.56  (2.90)
Backward: Baseline 7.09  (2.39)
Backward: Week 12 7.32  (2.41)
8.Secondary Outcome
Title Finger Window (FW) Test Score
Hide Description In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Forward FW: Baseline 18.42  (4.60)
Forward FW: Week 12 19.09  (4.49)
Backward FW: Baseline 15.59  (4.97)
Backward FW: Week 12 17.36  (3.84)
9.Secondary Outcome
Title Controlled Oral Words Association Test (COWAT) Score
Hide Description This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: Words
Category/semantic: Baseline 29.71  (5.86)
Category/semantic: Week 12 30.62  (6.16)
Letter/phenomic: Baseline 28.71  (10.82)
Letter/phenomic: Week 12 33.78  (11.18)
10.Secondary Outcome
Title Stroop Test Result for Reaction Time
Hide Description This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: Seconds
Simple execution time: Baseline 14.78  (3.8)
Simple execution time: Week 12 13.64  (3.27)
Middle execution time: Baseline 15.88  (3.56)
Middle execution time: Week 12 15.04  (4.57)
Interfering execution time: Baseline 22.12  (6.18)
Interfering execution time: Week 12 19.72  (5.63)
11.Secondary Outcome
Title Stroop Test Result for False Reaction
Hide Description This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: Errors
Simple execution false reaction: Baseline 0.4  (0.77)
Simple execution false reaction: Week 12 0.16  (0.39)
Middle execution false reaction: Baseline 0.3  (0.67)
Middle execution false reaction: Week 12 0.2  (0.47)
Interfering execution false reaction: Baseline 1.04  (1.29)
Interfering execution false reaction: Week 12 0.84  (1.00)
12.Secondary Outcome
Title Stroop Test Score for Ratio Interference
Hide Description Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description:
Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 0.70  (0.19)
Week 12 0.72  (0.19)
Time Frame After signing of informed consent up to Week 12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OROS Methylphenidate HCl
Hide Arm/Group Description Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
All-Cause Mortality
OROS Methylphenidate HCl
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OROS Methylphenidate HCl
Affected / at Risk (%)
Total   2/113 (1.77%) 
Blood and lymphatic system disorders   
Lymphadenitis * 1  1/113 (0.88%) 
Infections and infestations   
Appendicitis * 1  1/113 (0.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OROS Methylphenidate HCl
Affected / at Risk (%)
Total   98/113 (86.73%) 
Cardiac disorders   
Palpitations * 1  8/113 (7.08%) 
Gastrointestinal disorders   
Nausea * 1  32/113 (28.32%) 
Abdominal pain upper * 1  19/113 (16.81%) 
Stomach discomfort * 1  15/113 (13.27%) 
Vomiting * 1  7/113 (6.19%) 
Diarrhoea * 1  6/113 (5.31%) 
General disorders   
Irritability * 1  16/113 (14.16%) 
Fatigue * 1  13/113 (11.50%) 
Infections and infestations   
Nasopharyngitis * 1  19/113 (16.81%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  66/113 (58.41%) 
Musculoskeletal and connective tissue disorders   
Myalgia * 1  6/113 (5.31%) 
Nervous system disorders   
Headache * 1  31/113 (27.43%) 
Dizziness * 1  11/113 (9.73%) 
Somnolence * 1  8/113 (7.08%) 
Psychiatric disorders   
Insomnia * 1  37/113 (32.74%) 
Anxiety * 1  9/113 (7.96%) 
Depression * 1  9/113 (7.96%) 
Nervousness * 1  7/113 (6.19%) 
Anger * 1  6/113 (5.31%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
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: Clinical Research Director
Organization: Medical Affairs / Janssen-Cil Korea
Phone: 82-2-2094-4518
Layout table for additonal information
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01060150     History of Changes
Other Study ID Numbers: CR015496
CON-KOR-4019
CONCERTAATT4082
First Submitted: January 21, 2010
First Posted: February 2, 2010
Results First Submitted: March 19, 2013
Results First Posted: July 31, 2013
Last Update Posted: August 23, 2013