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Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

NCT01323790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2015-06-02

Study results available
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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).

Conditions

  • Opioid-Induced Constipation (OIC)

Interventions

DRUG

NKTR-118

12.5 mg oral tablet once daily

DRUG

NKTR-118

25 mg oral tablet once daily

DRUG

Placebo

Placebo to NKTR-118

Sponsors & Collaborators

Principal Investigators

  • Mark Sostek · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Belgium
  • Croatia
  • Czechia
  • Hungary
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01323790 on ClinicalTrials.gov