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

Completed · Phase 2 · Has a placebo group

Conditions studied: Opioid Induced Bowel Dysfunction

In brief

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

Key facts

Study ID

NCT01122030

Run by

Shionogi

People needed

72

Starts

2010-05-19

Expected to finish

2011-03-22

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shionogi Research Site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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