Opioid Induced Bowel Dysfunction Clinical Trial
Official title:
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
Study consists of 6 treatment cohorts of 12 subjects with chronic pain, opioid-induced bowel
dysfunction, and opioid physical dependence. Total duration of treatment for each subject
will be up to 28 days.
Each subject will receive a single dose of study drug, administered orally in the morning of
Day 15 under fasted conditions.
Cohort 1: 0.1 mg of S-297995 or placebo. Cohort 2: 0.3 mg of S-297995 or placebo. Cohort 3:
1 mg of S-297995 or placebo. Cohort 4: 3 mg of S-297995 or placebo. Cohort 5: 0.03 mg of
S-297995 or placebo. Cohort 6: 0.01 mg of S-297995 or placebo.
The primary objective of the study is to evaluate the safety of single doses of oral
S-297995 in subjects physically dependent on opioids
A single dose of S-297995 or matching placebo will be administered orally to each cohort of 12 subjects (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 ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment