NCT01382797已完成2 期
A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose Study to Evaluate the Safety, Tolerability, and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Are at least 18 years of age at time of consent
- •Have a body mass index (BMI)of 19 to 35 kg/m2 at screening
- •Are receiving prescribed opioid medication for the management of chronic, non-cancer pain
- •Meet the criteria of OIC
- •Agree to use an acceptable method of contraception for the duration of the study
排除标准
- •Pregnancy and/or currently breastfeeding
- •Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)
- •Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction
- •Any gastrointestinal (GI) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction
- •Use of naloxone, Subutex or Suboxone, Revia, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study
- •Participation in a clinical trial of a pharmacological agent within 30 days before screening
研究组 & 干预措施
Placebo
Placebo Comparator
Capsules for oral administration
干预措施: Placebo (Drug)
ALKS 37
Experimental
Capsules for oral administration
干预措施: ALKS 37 (Drug)
结局指标
主要结局
Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.
时间窗: 4 weeks
Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.
次要结局
未报告次要终点
研究者
研究点 (2)
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