At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 547 enrolled
Drug / intervention
Naldemedine +1 moredrug
Likely dose
Naldemedine 0.2 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.
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy
In Brief
A Phase 3 clinical trial evaluating Naldemedine and Placebo for Opioid-induced Constipation. Completed, enrolled 547 participants across 65 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-induced Constipation
CountriesAustria, Czechia, Germany, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedOct 2013
Primary CompletionJan 2015
TodayJul 2026
First PostedOct 18, 2013
Enrollment StartAug 29, 2013
Primary CompletionJan 22, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.7 years ago
Interventions
Naldemedinedrug
Naldemedine 0.2 mg tablet taken orally once a day
Placebodrug
Placebo tablet taken orally once a day