A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)

Study identifier:07-IN-NX003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients with Opioid-Induced Constipation (OIC)

Medical condition

Opioid induced constipation (OIC)

Phase

Phase 2

Healthy volunteers

No

Study drug

placebo, NKTR-118

Sex

All

Actual Enrollment

224

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Dec 2007
Primary Completion Date: 01 Mar 2009
Study Completion Date: 01 Apr 2009

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

Sponsors

AstraZeneca

Collaborators

Nektar Therapeutics

Inclusion and exclusion criteria