drugset / Trial / NCT01207427

Evaluation of the Efficacy and Safety of ADL5945 for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain

NCT01207427 ↗

Phase 2 Completed 131 enrolled Merck & Co., Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI tract. The most common symptoms associated with the effects of opioids are constipation and nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of long-term opioid therapy. The primary objective of this study was to compare ADL5945, a MOR antagonist, with placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy for chronic noncancer pain.

Timeline

Start
2010-10-14
Primary completion
2011-04-18
Completion
2011-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject bevenopran Small molecule 0.1 mg Oral
Subject bevenopran Small molecule 0.25 mg Oral