NCT01122030

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

A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety and Efficacy of S-297995 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A single dose of naldemedine or matching placebo will be administered orally to each cohort of 12 participants (9 treatments, 3 placebos) in the morning of Day 15 under fasted conditions. The first cohort will receive a 0.1 mg dose. Cohorts will continue to be enrolled at the next higher dose level until the highest dose level (3 mg) has been achieved or until the study is discontinued due to adverse events or Clinical Opioid Withdrawal Score of \>8. A 0.03 mg dose will also be tested. A 0.01 mg dose will be tested if 4 or more subjects experience 1 or more bowel movements within the 24 hour period post dose in the 0.03 mg dosing cohort.

Conditions

• Opioid Induced Bowel Dysfunction

Interventions

Type	Name	Description
DRUG	Naldemedine	Tablets or solution for oral administration
DRUG	Placebo	Tablets or solution for oral administration

Timeline

• Start date: 2010-05-19
• Primary completion: 2011-02-23
• Completion: 2011-03-22
• First posted: 2010-05-12
• Last updated: 2017-05-30
• Results posted: 2017-05-30

Locations

1 site across 1 country: United States