A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy - COMPOSE I

Shionogi Inc.0 个研究点目标入组 540 人开始时间: 2013年10月22日最近更新: 2016年3月14日

适应症

试验速览

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•1. Subjects aged 18 to 80 years inclusive at the time of informed consent
•2. Subjects must have non-malignant chronic pain treated with opioids for at least 3 months and must have OIC
•3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of = 30 mg equivalents of oral morphine sulfate for at least 1 month prior to Screening
•4. Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration
•5. Subjects must meet criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 290

•1. Evidence of significant structural abnormalities of the gastrointestinal tract (GI)
•2. Evidence of active medical diseases affecting bowel transit
•3. History or presence of pelvic disorders that may be a cause of constipation
•4. Surgery (except for minor procedures) within 60 days of Screening
•5. History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical gastrointestinal obstruction)
•6. Subjects who have never taken laxatives for the treatment of OIC
•7. History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected or tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of breast cancer)

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