drugset / Trial / NCT01443403

A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy

NCT01443403

Phase 2 Completed 244 enrolled Shionogi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.

Timeline

Start
2011-08-17
Primary completion
2012-08-22
Completion
2012-08-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Naldemedine Other / unclassified 0.1 mg Oral
Subject Naldemedine Other / unclassified 0.2 mg Oral
Subject Naldemedine Other / unclassified 0.4 mg Oral