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Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

NCT01384292 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-06-01

Study results available
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Summary

The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).

Conditions

  • Opioid-Induced Constipation

Interventions

DRUG

NKTR-118

12.5 mg oral tablet once daily

DRUG

NKTR-118

25 mg oral tablet once daily

DRUG

Placebo

Oral treatment

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Germany
  • Poland
  • Puerto Rico
  • Romania
  • Slovakia
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT01384292 on ClinicalTrials.gov