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ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])

Information source: Alkermes, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcoholism; Opiate Dependence

Intervention: Medisorb naltrexone 380 mg (Drug); Oral naltrexone to Medisorb naltrexone 380 mg (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Alkermes, Inc.

Official(s) and/or principal investigator(s):
Bernard L. Silverman, MD, Study Director, Affiliation: Alkermes, Inc.

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.

Clinical Details

Official title: An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Primary Inclusion Criteria:

- Adults with a diagnosis of alcohol and/or opioid dependence as defined by the

Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) who had satisfactorily completed Alkermes' Study ALK21-006 or other qualifying Medisorb naltrexone study

- Willing and able to return for scheduled clinic visits and study assessments

- Had a stable address

- Agreed to use a contraception for the duration of the study and for 1 month following

the last dose if of childbearing potential

- Written informed consent

Primary Exclusion Criteria:

- Pregnancy or lactation

- Terminated early from study drug in a previous Medisorb naltrexone clinical trial

- Any finding that, in the view of the investigator, would compromise the ability to

fulfill the protocol visit schedule and/or visit requirements

Locations and Contacts

Additional Information

Starting date: August 2004
Last updated: November 5, 2010

Page last updated: August 23, 2015

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