Long Term Safety of Naldemedine
CompletedPhase 3NCT01965652
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.
Study details
- Official title
- A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy
- Conditions
- Opioid-induced Constipation
- Interventions
- Sponsor
- Shionogi
- Organization
- Shionogi Inc.
- Start date
- 2013-09-24
- Primary completion
- 2016-01-12
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Australia, Austria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Poland, South Africa, Spain, Sweden, United Kingdom, United States
- Total sites listed
- 186
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria 1. Subjects aged 18 to 80 years inclusive at the time of informed consent 2. Subjects must have non-malignant chronic pain treated and must have opioid induced constipation (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 4. Subjects may or may not be on a routine laxative regimen at the time of Screening Exclusion Criteria 1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract 2. Evidence of active medical diseases affecting bowel transit 3. History 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 GI obstruction) 6. Subjects who have never taken laxatives for the treatment of OIC 7. Current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists
Canadian sites (6)
| Facility | City | Province |
|---|---|---|
| Shionogi Research Site | London | |
| Shionogi Research Site | Mirabel | |
| Shionogi Research Site | Sarnia | |
| Shionogi Research Site | Sherbrooke | |
| Shionogi Research Site | Toronto | |
| Shionogi Research Site | Vancouver |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01965652