A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
CompletedPhase 2NCT01443403
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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 purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
Study details
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 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
- 2011-08-17
- Primary completion
- 2012-08-22
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 49
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation * Subjects with \< 3 spontaneous bowel movements a week and experiencing bowel symptoms * Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months Exclusion Criteria: * Evidence of clinically significant gastrointestinal disease * 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 * Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01443403