Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy
- Conditions
- Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid TherapyMedDRA version: 17.1Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000004856Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2013-002241-11-DE
- Lead Sponsor
- Shionogi Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of naldemedine compared to placebo without concomitant laxative treatment in subjects with non-malignant chronic pain receiving a stable opioid regimen for =1 month and having OIC;Secondary Objective: To evaluate the efficacy of naldemedine on the frequency of Spontaneous Bowel Movements (SBMs) and SBMs without straining. To evaluate the safety and tolerability of naldemedine<br>;Primary end point(s): The primary efficacy endpoint will be the proportion of responders. A positive response week will be defined as = 3 SBMs per week and an increase from baseline of = 1 SBM per week for that week. <br>Any number of SBMs rated on the Bristol Stool Scale as 1 within a 2 hour period will be counted as a single SBM.<br>;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Mean change in the frequency of SBMs per week from baseline to the first four weeks of the Treatment Period<br>2- Mean change in the frequency of SBMs per week without straining from baseline to the last two weeks of the Treatment Period <br>3- Mean change in the frequency of SBMs per week from baseline to each two weeks of the Treatment Period<br>;Timepoint(s) of evaluation of this end point: 1- Week 4<br>2- Last two weeks of the Treatment Period<br>3- Every two weeks