An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 108
- 主要终点
- Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Medisorb naltrexone 380 mg (VIVITROL)
干预措施: Medisorb naltrexone 380 mg (Drug)
Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL)
干预措施: Oral naltrexone to Medisorb naltrexone 380 mg (Drug)
结局指标
主要结局
Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
时间窗: Up to 3 years
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 through the end of the follow-up period).
次要结局
未报告次要终点