ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)

This study has been completed.
Sponsor:
Information provided by:
Alkermes
ClinicalTrials.gov Identifier:
NCT01218997
First received: October 8, 2010
Last updated: December 27, 2010
Last verified: December 2010
Results First Received: November 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Drug: Medisorb naltrexone 380 mg
Drug: Oral naltrexone 50 mg

  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
Enrollment was monitored to ensure adequate representation of alcohol-dependent and opioid-dependent patients as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria, and was stratified by alcohol dependence alone versus opioid or mixed substance abuse (ie, alcohol and opioid dependence).

Reporting Groups
  Description
Medisorb Naltrexone 380 mg (VIVITROL) Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
Oral Naltrexone 50 mg Oral tablet taken once each day for up to 1 year.

Participant Flow:   Overall Study
    Medisorb Naltrexone 380 mg (VIVITROL)     Oral Naltrexone 50 mg  
STARTED     371     65  
COMPLETED     126     24  
NOT COMPLETED     245     41  



  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
Medisorb Naltrexone 380 mg (VIVITROL) Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
Oral Naltrexone 50 mg Oral tablet taken once each day for up to 1 year.
Total Total of all reporting groups

Baseline Measures
    Medisorb Naltrexone 380 mg (VIVITROL)     Oral Naltrexone 50 mg     Total  
Number of Participants  
[units: participants]
  371     65     436  
Age  
[units: participants]
     
<=18 years     3     0     3  
Between 18 and 65 years     364     64     428  
>=65 years     4     1     5  
Age  
[units: years]
Mean ± Standard Deviation
  40.7  ± 11.2     40.5  ± 11.4     40.7  ± 11.3  
Gender  
[units: participants]
     
Female     138     23     161  
Male     233     42     275  
Region of Enrollment  
[units: participants]
     
United States     371     65     436  



  Outcome Measures

1.  Primary:   Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study   [ Time Frame: up to 1 year ]


  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 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.


Results Point of Contact:  
Name/Title: Bernard L. Silverman
Organization: Alkermes, Inc.
phone: 781-609-6000
e-mail: bernard.silverman@alkermes.com


No publications provided


Responsible Party: Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01218997     History of Changes
Other Study ID Numbers: ALK21-006
Study First Received: October 8, 2010
Results First Received: November 8, 2010
Last Updated: December 27, 2010
Health Authority: United States: Food and Drug Administration