Phase 3
Completed N=332
ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
Source: ClinicalTrials.gov NCT01218971 ↗Enrolled (actual)
332
Serious AEs
5.4%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study — 143; 130 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study |
143; 130 | — |
Eligibility Criteria
Primary Inclusion Criteria:
- 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 Criteria:
- Positive urine drug screen for opioids at Visit 1
- Early termination of study drug in the base study
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT01218971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.