ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT00834080
First received: February 2, 2009
Last updated: May 30, 2013
Last verified: May 2013
Results First Received: May 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Opiate Dependence
Intervention: Drug: Medisorb naltrexone 380 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
This study had a 12 month recruitment period (May 2009 through April 2010). A total of 11 sites in the United States participated. Principal Investigators were addiction specialists who had contact with health care professionals in need of treatment for opioid dependence.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Potential subjects must have participated in a detoxification program for opioid dependence. Subjects participated in psychosocial treatment throughout their study participation.

Reporting Groups
  Description
VIVITROL Study drug was administered by intramuscular (IM) injection once monthly for 24 months.

Participant Flow:   Overall Study
    VIVITROL  
STARTED     38  
COMPLETED     15  
NOT COMPLETED     23  
Adverse Event                 7  
Lost to Follow-up                 7  
Withdrawal by Subject                 5  
Other - Pregnancy                 1  
Other - False positive tests of the UDS                 1  
Physician Decision                 1  
Subject Relocated                 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.
The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data.

Reporting Groups
  Description
VIVITROL, 380mg No text entered.

Baseline Measures
    VIVITROL, 380mg  
Number of Participants  
[units: participants]
  38  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     38  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.4  ± 10.39  
Gender  
[units: participants]
 
Female     31  
Male     7  
Region of Enrollment  
[units: participants]
 
United States     38  



  Outcome Measures

1.  Primary:   Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.   [ Time Frame: 2 years (Baseline to end of study) ]


  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
After screening 49 subjects, Alkermes made a business decision to stop enrollment, resulting in 38 total subjects enrolled.


  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, MD
Organization: Alkermes, Inc.
phone: 781-609-6000
e-mail: Bernard.Silverman@alkermes.com


No publications provided


Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT00834080     History of Changes
Other Study ID Numbers: ALK21-021
Study First Received: February 2, 2009
Results First Received: May 30, 2013
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration