Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
CompletedPhase 2NCT01122030
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.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
Study details
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety and Efficacy of S-297995 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
- Conditions
- Opioid Induced Bowel Dysfunction
- Interventions
- Sponsor
- Shionogi
- Organization
- Shionogi Inc.
- Start date
- 2010-05-19
- Primary completion
- 2011-02-23
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Understand and sign an informed consent form * Males will agree to use an approved double-barrier method of contraception from Day 1 until 1 month after study completion * Subject tests negative on urine drug test unless the subject has a prescription for the drug(s) that test positive Exclusion Criteria: * Subjects under opioid therapy for cancer-related pain or for the management of drug addiction * Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea, intermittent loose stools, or constipation * Subjects who have participated in any other investigational drug study within 30 days prior to Day 1 * Prior exposure to S-297995
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01122030