Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156936
Status:
TERMINATED
Last Update Posted:
2010-11-17
First Post:
2005-09-07
Brief Title:
ALK21-006EXT Long-term Safety of Medisorb Naltrexone VIVITROL in Alcohol- or Opioid-dependent Adults Extension of Study ALK21-006 NCT01218997
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
An Open-Label Multi-Center Study to Evaluate the Long-Term Safety of Medisorb Naltrexone
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a multicenter extension of Alkermes Study ALK21-006 NCT01218997 designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection All subjects received open-label Medisorb naltrexone 380 mg VIVITROL
Planned treatment duration was up to 3 years Alkermes terminated the study for business purposes in December 2006 The median duration of treatment among all subjects in this extension study was 43 weeks
Planned treatment duration was up to 3 years Alkermes terminated the study for business purposes in December 2006 The median duration of treatment among all subjects in this extension study was 43 weeks
Detailed Description:
From the date of successful completion of Study ALK21-006 base study NCT01218997 all subjects including those who received oral naltrexone during the base study were given the option to enroll in this extension study
Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy If the investigator suspected recent clinically significant opioid use a naloxone challenge test was performed The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids
Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy If the investigator suspected recent clinically significant opioid use a naloxone challenge test was performed The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids
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