A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00302458
First received: March 13, 2006
Last updated: November 18, 2013
Last verified: November 2013
Results First Received: November 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Healthy
Interventions: Drug: OROS-Methylphenidate
Drug: Immediate Release Methylphenidate

  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
Subjects were enrolled from 2005 to 2007 at Massachusetts General Hospital and were recruited using IRB approved postings through web and email.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Based on a comprehensive screening, subjects who did not meet eligibility criteria for the study were excluded. Others withdrew or were lost to follow-up before randomization.

Reporting Groups
  Description
Healthy Volunteers Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.

Participant Flow:   Overall Study
    Healthy Volunteers  
STARTED     29  
COMPLETED     26  
NOT COMPLETED     3  
Lost to Follow-up                 1  
Ineligible after screening                 1  
Withdrawal by Subject                 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.
One subject was ineligible, one subject was lost to follow-up, one withdrew, and twenty six subjects completed the study.

Reporting Groups
  Description
Healthy Volunteers Healthy volunteers each received IR-MPH, OROS-MPH, and matched placebo (in four separate visits) in a four way crossover design.

Baseline Measures
    Healthy Volunteers  
Number of Participants  
[units: participants]
  29  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.86  ± 6.06  
Gender  
[units: participants]
 
Female     15  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     29  



  Outcome Measures

1.  Primary:   Peak Plasma Concentration of d-Methylphenidate   [ Time Frame: 4 hours ]


  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 NOT 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:  
Name/Title: Dr. Thomas Spencer
Organization: Massachusetts General Hospital
phone: 617-726-1731
e-mail: spencer@helix.mgh.harvard.edu


No publications provided by Massachusetts General Hospital

Publications automatically indexed to this study:

Responsible Party: Thomas J. Spencer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00302458     History of Changes
Other Study ID Numbers: 2005-P-001812
Study First Received: March 13, 2006
Results First Received: November 18, 2013
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board