At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 302 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 12-Week Extension Study to Assess the Safety and Tolerability 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 302 participants across 116 sites in 4 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 over a 6-month period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Induced Constipation (OIC)
CountriesAustralia, Germany, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedJul 2011
Primary CompletionSep 2012
TodayJul 2026
First PostedJul 15, 2011
Enrollment StartJul 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.0 years ago
Interventions
NKTR-118drug
12.5 mg oral tablet once daily
NKTR-118drug
25 mg oral tablet once daily
Placebodrug
Oral tablet intake once daily