A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Non-Malignant Pain

Bausch Health Americas, Inc.67 个研究点分布在 1 个国家目标入组 420 人开始时间: 2006年8月最近更新: 2019年11月25日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Bausch Health Americas, Inc.
入组人数: 420
试验地点: 67
主要终点: The effect of the interventional treatment will be measured by the change from baseline in the number of bowel movements per week during the double-blind treatment period.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.

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: Double

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

•Adult outpatients with opioid-induced bowel dysfunction and chronic non-malignant pain.
•Taking oral, transdermal, intravenous, or subcutaneous opioids.
•Willingness to discontinue all pre-study laxative therapy and utilize only study permitted rescue laxatives.

排除标准

•History of chronic constipation before the initiation of opioid therapy.
•Other GI disorders known to affect bowel transit.
•Women who are pregnant, breast-feeding, or plan to become pregnant.

结局指标

主要结局

The effect of the interventional treatment will be measured by the change from baseline in the number of bowel movements per week during the double-blind treatment period.

次要结局

未报告次要终点

研究者

发起方

Bausch Health Americas, Inc.

申办方类型

Industry

研究点 (67)

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