Who is sponsoring NCT00156923?

NCT00156923 is sponsored by Alkermes, Inc..

What condition does NCT00156923 study?

NCT00156923 studies Alcoholism.

What drugs are being tested in NCT00156923?

Interventions: Medisorb naltrexone 380 mg, Medisorb naltrexone 190 mg.

What is the status of NCT00156923?

NCT00156923 is currently COMPLETED.

Last reviewed 2017-06-08 · How we verify

A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone

NCT00156923 Phase 3 COMPLETED Results posted

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®).

Details

Lead sponsor	Alkermes, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	108
Start date	2003-10
Completion	2007-01

Conditions

Alcoholism

Interventions

Medisorb naltrexone 380 mg
Medisorb naltrexone 190 mg

Primary outcomes

Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) — Up to 3.5 years of monthly treatment
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period).