At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 844 enrolled
Drug / intervention
NKTR-118 +1 moredrug
Likely dose
NKTR-118 25 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.
An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain
In Brief
A Phase 3 clinical trial evaluating NKTR-118 and Usual care for Opioid-Induced Constipation (OIC). Completed, enrolled 844 participants across 169 sites.
Detailed Summary
The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Induced Constipation (OIC)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedApr 2011
Primary CompletionDec 2012
TodayJul 2026
First PostedApr 15, 2011
Enrollment StartApr 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.2 years ago
Interventions
NKTR-118drug
25 mg oral tablet once daily
Usual caredrug
As prescribed by the investigator