ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00156923|
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : December 3, 2010
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Drug: Medisorb naltrexone 380 mg Drug: Medisorb naltrexone 190 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
|Experimental: Medisorb naltrexone 380 mg||
Drug: Medisorb naltrexone 380 mg
Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.
|Experimental: Medisorb naltrexone 190 mg||
Drug: Medisorb naltrexone 190 mg
Administered via IM injection once every 4 weeks for up to 3.5 years.
Other Name: Naltrexone for extended-release injectable suspension
- Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156923
|Study Director:||Bernard L. Silverman, MD||Alkermes, Inc.|