Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-I… (NCT01122030) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
United States72 participantsStarted 2010-05-19
Plain-language summary
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: From the first dose of study drug on Day 15 up to Day 24.