drugset / Trial / NCT01275755

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

NCT01275755 ↗

Phase 2 Completed 81 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 once daily, 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
2011-01-19
Primary completion
2011-07-15
Completion
2011-07-15

Drugs

EvaluationDrugModalityDoseRoute
Subject bevenopran Small molecule 0.25 mg Oral

Indications