NCT02641301

Sustained-release Morphine Pharmacokinetics in Roux-en-Y Gastric Bypass Subjects

Study of the Concentrations of Long Acting Morphine After Oral Absorption in Subjects Who Underwent Gastric Bypass (OBEMO 2)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hopital Lariboisière · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether sustained release morphine pharmacokinetics parameters in patients undergone roux-en-y gastric bypass (RYGB) differ from subjects who did not. Our hypothesis is that exposure is comparable. Indeed, in the Study OBEMO (Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass; NCT00943969) the investigators observed changes in pharmacokinetics parameters for immediate release morphine, probably due to an earlier absorption of the morphine, in agreement with the expected clinical effect of this formulation.

Detailed description

This is an open label study with two arms: patients undergone roux-en-y gastric bypass and volunteers who did not matched by sex, age and Body Mass Index (BMI). In the pharmacokinetic visit the subject takes an oral administration of sustained release morphine, 30 mg, then 11 samples are collected during 12 hours.

Conditions

• Bypass Complications

Interventions

Type	Name	Description
DRUG	Sustained release morphine sulfate, 30 mg	A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2015-12-29
• Last updated: 2016-11-29

Locations

2 sites across 1 country: France