This trial is active, not recruiting.

Condition opioid-induced constipation
Treatments naldemedine, placebo
Phase phase 3
Sponsor Shionogi
Start date August 2013
End date January 2016
Trial size 1200 participants
Trial identifier NCT01965652, 1326V9235


The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Subjects will receive a single tablet of naldemedine once daily for the duration of the 52 week treatment period
Naldemedine tablet from weeks 1-52
Subjects will receive a single tablet of placebo once daily for the duration of the 52 week treatment period
Placebo tablet from weeks 1-52

Primary Outcomes

Incidence of adverse events (AEs), serious adverse events (SAEs) and AEs leading to discontinuation
time frame: Baseline to end of 52 week treatment period

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Description This is a Phase 3, multi-center, randomized double-blind, placebo controlled, parallel-group study designed to evaluate the long term safety of naldemedine compared to placebo for the treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain receiving opioid therapy.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Shionogi Inc..