At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 72 enrolled
Drug / intervention
Naldemedine +1 moredrug
Likely dose
Not stated in 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.
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
In Brief
A Phase 2 clinical trial evaluating Naldemedine and Placebo for Opioid Induced Bowel Dysfunction. Completed, enrolled 72 participants across 1 site.
Detailed Summary
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Induced Bowel Dysfunction
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartMay 2010
Primary CompletionFeb 2011
Study CompletionMar 2011
TodayJul 2026
First PostedMay 12, 2010
Enrollment StartMay 19, 2010
Primary CompletionFeb 23, 2011
Study CompletionMar 22, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.1 years ago
Interventions
Naldemedinedrug
Tablets or solution for oral administration
Placebodrug
Tablets or solution for oral administration