Status:
COMPLETED
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
Lead Sponsor:
Alkermes, Inc.
Conditions:
Alcoholism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).
Detailed Description
Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low)...
Eligibility Criteria
Inclusion
- Primary
- Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections
- Willing and able to return for scheduled clinic visits and study assessments
- Noncustodial, stable address and phone
- Written, informed consent
- Primary
Exclusion
- Pregnancy or lactation
- Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00156923
Start Date
October 1 2003
End Date
January 1 2007
Last Update
July 11 2017
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