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Study to Evaluate the Indication of Induced Bowel Dysfuction, Associated With Chronic Opioid Therapy

2014-08-27 03:13:46 | BioPortfolio

Summary

Study consists of 6 treatment cohorts of 12 subjects with chronic pain, OBD and opioid physical dependence. Total duration of treatment for each subject will be up to 28-days.

Each subject will receive single dose of study drug, administered orally.

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: 6 mg of S-297995 or placebo. Cohort 6: 10 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 dependant on opioids.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Opioid Induced Bowel Dysfuction

Intervention

S-297995, Placebo

Location

Lifetree Clinical Research
Salt Lake City
Utah
United States
84106

Status

Enrolling by invitation

Source

Shionogi USA, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:46-0400

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