NCT01117376

Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients

Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are recruited. All patients enter a primary acetaminophen absorption test study as baseline. Serum levels of acetaminophen will be measured by florescence polarization method at 15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen. Then the patients will be randomized to methylnaltrexone or erythromycin group.Another acetaminophen absorption test with the same schedule will be done after the last dose of each drug.The area under the curve for acetaminophen blood level will be used to compare the effect of two studied drugs on gastric emptying time.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DRUG	Erythromycin	Erythromycin 250 mg intravenous Q6h for 4 doses
DRUG	Methylnaltrexone	Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-06-01
• Completion: 2011-08-01
• First posted: 2010-05-05
• Last updated: 2011-03-31

Locations

1 site across 1 country: Iran