drugset / Trial / NCT01122030

Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

NCT01122030

Phase 2 Completed 72 enrolled Shionogi
RandomizedSingle-groupTriple-blindTreatment

Summary

The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.

Timeline

Start
2010-05-19
Primary completion
2011-02-23
Completion
2011-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Naldemedine Other / unclassified 0.01 mg Oral
Subject Naldemedine Other / unclassified 0.03 mg Oral
Subject Naldemedine Other / unclassified 0.1 mg Oral
Subject Naldemedine Other / unclassified 0.3 mg Oral
Subject Naldemedine Other / unclassified 1 mg Oral
Subject Naldemedine Other / unclassified 3 mg Oral