Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain who are not using laxatives
Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy
Enrollment: 540
Study Start Date: August 2013
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms:
- Subjects on naldemedine
- Subjects on placebo
Category | Value |
---|---|
Study start date | 2013-08-01 |