NCT01050595

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: St. John Health System, Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid-induced Constipation

Interventions

Type	Name	Description
DRUG	Methylnaltrexone Bromide	The experimental group will receive the recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs). Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg. If creatinine clearance \<30 will decrease dose by 50%. This will be given after 72 hours of no bowel movement. Bowel management protocol will be instituted four hours afterward with the methylnaltrexone being given every other day.
DRUG	Placebo-Normal Saline	Control group will be given an equal amount of normal saline in an identically appearing vial every other day until a bowel movement occurs. A bowel management protocol will also be started.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-10-01
• Completion: 2010-12-01
• First posted: 2010-01-15
• Last updated: 2010-01-15

Locations

1 site across 1 country: United States