CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
ADL5945 0.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01275755
NCT01275755Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Jan 12, 2011·Updated Nov 15, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo and ADL5945 0.25 mg for Constipation. Completed, enrolled 81 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2011
Enrollment StartJan 19, 2011
Primary CompletionJul 15, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.5 years ago

Interventions

Placebodrug

ADL5945 0.25 mgdrug