CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 652 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.

Search/NCT01309841
NCT01309841Phase 3Completed
CompareCT.gov

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)

AstraZeneca·interventional·Posted Mar 7, 2011·Updated Jun 1, 2015

In Brief

A Phase 3 clinical trial evaluating NKTR-118 and Placebo for Opioid-Induced Constipation (OIC). Completed, enrolled 652 participants across 117 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, including those patients that have inadequate response to laxative therapy (LIR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Induced Constipation (OIC)
CountriesAustralia, Germany, Slovakia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2011
Enrollment StartMar 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.3 years ago

Interventions

NKTR-118drug

12.5 mg oral tablet once daily

NKTR-118drug

25 mg oral tablet once daily

Placebodrug

Oral tablet once daily