At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,246 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, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for 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 1,246 participants across 186 sites in 16 countries.
Detailed Summary
The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-induced Constipation
CountriesAustralia, Austria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Poland, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedOct 2013
Primary CompletionJan 2016
TodayJul 2026
First PostedOct 18, 2013
Enrollment StartSep 24, 2013
Primary CompletionJan 12, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 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