Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

• Status: Completed
• Trial end date: 2011-03-22
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.

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

Details

• Lead Sponsor: Shionogi
• Treatments: Analgesics, Opioid

Criteria

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