At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 700 enrolled
Drug / intervention
NKTR-118 +2 moredrug
Likely dose
NKTR-118 12.5 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 Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
In Brief
A Phase 3 clinical trial evaluating NKTR-118 and Placebo for Opioid-Induced Constipation (OIC). Completed, enrolled 700 participants across 120 sites in 8 countries.
Detailed Summary
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Induced Constipation (OIC)
CountriesBelgium, Croatia, Czechia, Hungary, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionSep 2012
TodayJul 2026
First PostedMar 28, 2011
Enrollment StartMar 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.3 years ago
Interventions
NKTR-118drug
12.5 mg oral tablet once daily
NKTR-118drug
25 mg oral tablet once daily
Placebodrug
Placebo to NKTR-118