NCT00943969

Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Hopital Lariboisière · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Different data suggest that this surgery may modify drug absorption and we think it would be clinically relevant to describe the consequences of gastric bypass on drug systemic exposure in obese patients, since no data on the comparison between the pharmacokinetics (PK) of a drug before and after surgery are available and help to predict the drugs posology.The investigators decided to study the morphine because there is a lack of information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range frequently prescribed in obese patients.

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	gastric bypass	gastric bypass combines restrictive and malabsorptive procedures

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-05-01
• Completion: 2010-01-01
• First posted: 2009-07-22
• Last updated: 2015-12-16

Locations

1 site across 1 country: France