drugset
drugset / Trial / NCT00936884

Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation

NCT00936884 ↗

Phase 3 Completed 50 enrolled Bausch Health Americas, Inc. Progenics Pharmaceuticals, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with opioid-induced constipation associated with advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) or chronic nonmalignant pain.

Timeline

Start
2009-07
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylnaltrexone Other / unclassified 0.15 mg/kg Subcutaneous
Subject Methylnaltrexone Other / unclassified 8 mg Subcutaneous
Subject Methylnaltrexone Other / unclassified 12 mg Subcutaneous

Indications

constipation disorder