CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 207 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
NKTR-118 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/NCT00600119
NCT00600119Phase 2Completed
CompareCT.gov

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients With Opioid-Induced Constipation (OIC)

AstraZeneca·interventional·Posted Jan 24, 2008·Updated Jun 12, 2015

In Brief

A Phase 2 clinical trial evaluating placebo and NKTR-118 for Opioid Induced Constipation (OIC). Completed, enrolled 207 participants across 33 sites.

Detailed Summary

Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Induced Constipation (OIC)
CountriesUnited States
CollaboratorsNektar Therapeutics

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2008
Enrollment StartDec 1, 2007
Primary CompletionMar 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.4 years ago

Interventions

placebodrug

placebo, oral, once daily (QD)

NKTR-118drug

5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)