drugset / Trial / NCT01218971
ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
Non-randomizedParallel-groupQuadruple-blindTreatment
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 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.
Timeline
- Start
- 2002-08
- Primary completion
- 2004-09
- Completion
- 2004-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 190 mg | — |
| Subject | Naltrexone | Small molecule | 380 mg | — |