Status:
COMPLETED
ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
Lead Sponsor:
Alkermes, Inc.
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 \[the base study\]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 w...
Detailed Description
All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone ...
Eligibility Criteria
Inclusion
- Primary
- Completed study drug treatment in Study ALK21-003 (base study \[NCT01218958\])
- Written informed consent for this extension study
- Stable address and telephone; reconfirmation of contact's address and phone
- Women with childbearing potential must agree to continue to use an approved method of birth control throughout study participation
- Primary
Exclusion
- Positive urine drug screen for opioids at Visit 1
- Early termination of study drug in the base study
- Pregnancy or lactation
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT01218971
Start Date
August 1 2002
End Date
September 1 2004
Last Update
December 24 2010
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