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Clinical trial

Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

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Last updated:1st Aug 2013

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

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