drugset / Trial / NCT01050595

Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit

NCT01050595

Phase 3 Unknown 80 enrolled St. John Health System, Michigan
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.

Timeline

Start
2009-12
Primary completion
2010-10
Completion
2010-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylnaltrexone Other / unclassified 0.15 mg/kg
Comparator Methylnaltrexone Other / unclassified 8 mg
Comparator Methylnaltrexone Other / unclassified 12 mg