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

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).


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Enrollment: 652
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Arms:
- Experimental: 1 (Oral treatment - 12.5 mg oral tablet once daily)
- Experimental: 2 (Oral treatment - 25 mg oral tablet once daily)
- Placebo Comparator: 3 (Oral treatment)


Related journal: Naloxegol for opioid-induced constipation in patients with noncancer pain