Characterization of Dermal Reactions in Pediatric Patients With Attention Deficit/Hyperactivity Disorder (ADHD) Using DAYTRANA

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00434213
First received: February 12, 2007
Last updated: January 3, 2011
Last verified: January 2011
Results First Received: February 4, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Intervention: Drug: Daytrana

  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
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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
Daytrana Methylphenidate Transdermal System (MTS)

Participant Flow:   Overall Study
    Daytrana  
STARTED     309  
COMPLETED     260  
NOT COMPLETED     49  
Adverse Event                 12  
Lack of Efficacy                 9  
Lost to Follow-up                 14  
Withdrawal by Subject                 7  
Protocol Violation                 3  
Unable to comply with study visit window                 2  
Application site reaction                 1  
Non-compliant to study schedule                 1  



  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.
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Reporting Groups
  Description
Daytrana Methylphenidate Transdermal System (MTS)

Baseline Measures
    Daytrana  
Number of Participants  
[units: participants]
  309  
Age  
[units: participants]
 
<=18 years     309  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  9.1  ± 1.95  
Gender  
[units: participants]
 
Female     91  
Male     218  
Region of Enrollment  
[units: participants]
 
United States     309  



  Outcome Measures
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1.  Primary:   Dermal Reactions   [ Time Frame: 7 weeks ]

2.  Secondary:   Contact Sensitization to Methylphenidate   [ Time Frame: 7 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Timothy Whitaker, M.D.
Organization: Shire Pharmaceutical Development Inc.
e-mail: twhitaker@shire.com


Publications of Results:
Warshaw EM, Squires L, Li Y, et al. Methylphenidate Transdermal System: A Multisite, Open-Label Study of Dermal Reactions in Pediatric Patients Diagnosed With ADHD. Primary Care Companion Journal Clinical Psychiatry; 12(6): e1-e9, 2010 (published online).


Responsible Party: Timothy Whitaker, M.D., Clinical Research and Development - VP of Global Clinical Medicine, Shire Pharmaceutical Development Inc.
ClinicalTrials.gov Identifier: NCT00434213     History of Changes
Other Study ID Numbers: SPD485-411
Study First Received: February 12, 2007
Results First Received: February 4, 2009
Last Updated: January 3, 2011
Health Authority: United States: Food and Drug Administration