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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01060150
First received: January 21, 2010
Last updated: August 14, 2013
Last verified: August 2013
Results First Received: March 19, 2013  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
OROS Methylphenidate HCl 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

Participant Flow:   Overall Study
    OROS Methylphenidate HCl
STARTED   115 
Treated   113 
COMPLETED   92 
NOT COMPLETED   23 
Adverse Event                6 
Lost to Follow-up                1 
Protocol Violation                6 
Withdrawal by Subject                8 
Enrolled, but not treated                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
OROS Methylphenidate HCl 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

Baseline Measures
   OROS Methylphenidate HCl 
Overall Participants Analyzed 
[Units: Participants]
 113 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.24  (1.43) 
Gender 
[Units: Participants]
 
Female   27 
Male   86 
Korean Version of Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 27.58  (8.92) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.88  (0.79) 
[1] 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] 
[Units: T-score]
Mean (Standard Deviation)
 40.97  (11.07) 
[1] 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.


  Outcome Measures
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1.  Primary:   Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score   [ Time Frame: Week 12 ]

2.  Primary:   Clinical Global Impression - Severity (CGI-S) Score   [ Time Frame: Week 12 ]

3.  Primary:   Clinical Global Impression - Improvement (CGI-I) Score   [ Time Frame: Week 12 ]

4.  Primary:   Learning Skill Test (LST) Total Score   [ Time Frame: Week 12 ]

5.  Secondary:   Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Digit Span Test Score   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Finger Window (FW) Test Score   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Controlled Oral Words Association Test (COWAT) Score   [ Time Frame: Baseline and Week 12 ]

10.  Secondary:   Stroop Test Result for Reaction Time   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Stroop Test Result for False Reaction   [ Time Frame: Baseline and Week 12 ]

12.  Secondary:   Stroop Test Score for Ratio Interference   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Research Director
Organization: Medical Affairs / Janssen-Cil Korea
phone: 82-2-2094-4518


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01060150     History of Changes
Other Study ID Numbers: CR015496
CON-KOR-4019
CONCERTAATT4082
Study First Received: January 21, 2010
Results First Received: March 19, 2013
Last Updated: August 14, 2013