A Multicenter Double-Blind Extension of Alkermes Study ALK21-003 to Evaluate the Long-Term Safety of Medisorb® Naltrexone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 332
- 主要终点
- Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study
研究概览
简要总结
This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.
详细描述
All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had received placebo for Medisorb naltrexone 190 mg in the base study were given Medisorb naltrexone 190 mg. Participants who had received placebo for Medisorb naltrexone 380 mg in the base study were given Medisorb naltrexone 380 mg.
Neither the identity or dose of the treatment received in the base study, nor the Medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension.
All participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory.
Participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received Medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (~1.5 years) upon completion of this extension. For participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Completed study drug treatment in Study ALK21-003 (base study [NCT01218958])
- •Written informed consent for this extension study
- •Stable address and telephone; reconfirmation of contact's address and phone
- •Women with childbearing potential must agree to continue to use an approved method of birth control throughout study participation
排除标准
- •Positive urine drug screen for opioids at Visit 1
- •Early termination of study drug in the base study
- •Pregnancy or lactation
研究组 & 干预措施
Medisorb naltrexone 380 mg
Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks.
干预措施: Medisorb naltrexone 380 mg (Drug)
Medisorb naltrexone 190 mg
IM injection administered once every 4 weeks for up to 48 weeks.
干预措施: Medisorb naltrexone 190 mg (Drug)
结局指标
主要结局
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study
时间窗: Up to 48 weeks (13 injections), not including base study
A TEAE is any adverse event, 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