A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy

• Status: Completed
• Trial end date: 2012-08-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shionogi
• Treatments: Analgesics, Opioid

Criteria

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