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

Study identifier:D3820C00006

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2011-001985-16

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 Relieving Opioid-Induced Constipation (OIC) in Patients with Cancer-Related Pain

Medical condition

Opioid-Induced Constipation

Phase

Phase 3

Healthy volunteers

No

Study drug

NKTR-118, Placebo

Sex

All

Actual Enrollment

336

Study type

Interventional

Age

18 Years +

Date

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

Study design

Allocation: Randomized
Endpoint Classification: Safety 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