ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
A Multicenter Double-Blind Extension of Alkermes Study ALK21-003 to Evaluate the Long-Term Safety of Medisorb® Naltrexone
研究概览
详细说明
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).
研究类型
注册 (实际的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Primary Inclusion Criteria:
- 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
Primary Exclusion Criteria:
- Positive urine drug screen for opioids at Visit 1
- Early termination of study drug in the base study
- Pregnancy or lactation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Medisorb naltrexone 380 mg
Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks.
|
naltrexone for extended-release injectable suspension
其他名称：
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实验性的：Medisorb naltrexone 190 mg
IM injection administered once every 4 weeks for up to 48 weeks.
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naltrexone for extended-release injectable suspension
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study
大体时间：Up to 48 weeks (13 injections), not including base study
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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).
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Up to 48 weeks (13 injections), not including base study
|
合作者和调查者
调查人员
- 研究主任：Bernard L Silverman, MD、Alkermes, Inc.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Medisorb naltrexone 380 mg的临床试验
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Alkermes, Inc.终止
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Aziende Chimiche Riunite Angelini Francesco S.p.AHippocrates Research招聘中
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New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)完全的