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

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

Outcome

Met primary endpoint

registry analysis (unspecified test); Methylnaltrexone Double-blind vs Placebo; p <0.0001; Odds Ratio (OR) 83.60 (97.5% CI 6.50 to 1074.7) NCT00936884 ↗

registry analysis (unspecified test); Methylnaltrexone Double-blind vs Placebo; p < 0.0001; Odds Ratio (OR) 23.38 (97.5% CI 10.91 to 50.14) NCT00936884 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylnaltrexone	Other / unclassified	0.15 mg/kg	Subcutaneous
Subject	Methylnaltrexone	Other / unclassified	8 mg	Subcutaneous
Subject	Methylnaltrexone	Other / unclassified	12 mg	Subcutaneous

Indications