Sustained-release Morphine Pharmacokinetics in Roux-en-Y Gastric Bypass Subjects (OBEMO2)

Hopital Lariboisière

Status and phase

Unknown

Phase 4

Conditions

Bypass Complications

Treatments

Drug: Sustained release morphine sulfate, 30 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02641301

OBEMO2

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

RYGB Group (n=12) :

Subjects who undergone RYGB for at least 24 months
Stable weight since almost one year (or weight loss below 10kg over the last year)

Control group (n=12) :

Volunteers subjects, matched for age, sex, and Body mass index
No history of bariatric surgery

Same characteristics

Subjects volunteers for the study
Age 20-65 years
Written consent

Exclusion criteria

Known allergy to morphine or naloxone
Patients not affiliated to the french social security system
Subjects yet recruited in a study with remuneration
Abnormalities in liver function Prothrombin ratio <70% and/ or aspartate transaminase > 5 times the usual values and/ or alanine aminotransferase >5 times the usual values and/ or in renal function (creatinine clearance Modification of Diet in Renal Disease (MDRD) < 60ml/ min
Respiratory insufficiency defined by an oximetry below 90%
Pregnancy and breastfeeding
Use of drugs contra-indicated or not advised with morphine:
Agonists-antagonists opioids ( buprenorphine, nalbuphine, pentazocine ), naltrexone
Alcohol intake > 30g by day
Cough medicine morphine-like ( dextromethorphan, noscapine, pholcodine )
Codeine, ethylmorphine
Other morphine agonist ( alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidine, remifentanil, sufentanil, tramadol )
Barbiturates, benzodiazepines
Rifampicin