Assessment of efficacy and safety in patients with non-cancer-related pain and opioid-induced constipation

Study identifier:D3820C00005

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2011-001986-41

CTIS identifier:N/A

Study Complete

Official Title

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)

Medical condition

Opioid-Induced Constipation (OIC)

Phase

Phase 3

Healthy volunteers

No

Study drug

NKTR-118, Placebo

Sex

All

Actual Enrollment

744

Study type

Interventional

Age

18 Years - 84 Years

Date

Study Start Date: 01 Mar 2011
Primary Completion Date: 01 Sept 2012
Study Completion Date: 01 Sept 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2014 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria