NCT01395524

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

A Randomized, Double-Blind, Placebo-Controlled 12-Week Extension Study to Assess the Safety and Tolerability of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (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 over a 6-month period.

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	Oral tablet intake once daily

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-07-15
• Last updated: 2017-02-23
• Results posted: 2015-06-17

Locations

116 sites across 4 countries: United States, Australia, Germany, Slovakia