At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 244 enrolled
Drug / intervention
Placebo +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, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy
In Brief
A Phase 2 clinical trial evaluating Placebo and Naldemedine for Opioid-induced Constipation. Completed, enrolled 244 participants across 49 sites.
Detailed Summary
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-induced Constipation
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedSep 2011
Primary CompletionAug 2012
TodayJul 2026
First PostedSep 29, 2011
Enrollment StartAug 17, 2011
Primary CompletionAug 22, 2012
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 14.8 years ago
Interventions
Placebodrug
Matching placebo tablets administered orally once a day.
Naldemedinedrug
Naldemedine tablets administered orally once a day.