MedTrace Logo

A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation

NCT01395524 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2017-02-23

Study results available
· View outcomes & findings →

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.

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

Oral tablet intake once daily

Sponsors & Collaborators

Principal Investigators

  • Mark Sostek · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Australia
  • Germany
  • Slovakia

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 NCT01395524 on ClinicalTrials.gov