NCT01323790

Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

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, including those patients that have inadequate response to laxative therapy (LIR).

Conditions

• Opioid-Induced Constipation (OIC)

Interventions

Type	Name	Description
DRUG	NKTR-118	12.5 mg oral tablet once daily
DRUG	NKTR-118	25 mg oral tablet once daily
DRUG	Placebo	Placebo to NKTR-118

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-03-28
• Last updated: 2015-06-02
• Results posted: 2015-06-02

Locations

120 sites across 8 countries: United States, Belgium, Croatia, Czechia, Hungary, Spain, Sweden, United Kingdom