NCT01336205

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

An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 844 (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 long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.

Conditions

• Opioid-Induced Constipation (OIC)

Interventions

Type	Name	Description
DRUG	NKTR-118	25 mg oral tablet once daily
DRUG	Usual care	As prescribed by the investigator

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-04-15
• Last updated: 2014-10-20
• Results posted: 2014-10-20

Locations

169 sites across 1 country: United States