Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156923
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2005-09-07
Brief Title:
ALK21-010 Long-term Safety of Medisorb Naltrexone VIVITROL in Alcohol-dependent Adults
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Multi-Center Extension of Alkermes Study ALK21-003-EXT NCT01218971 to Evaluate the Long-Term Safety of Medisorb Naltrexone
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 was not revealed to the subject the study investigators or any blinded member of the clinical study team for the duration of the study period Placebo was not administered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None