Overview

This trial is active, not recruiting.

Condition bypass complications
Treatment sustained release morphine sulfate, 30 mg
Phase phase 4
Sponsor Hopital Lariboisière
Start date December 2015
End date December 2016
Trial size 24 participants
Trial identifier NCT02641301, OBEMO2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Sustained release morphine sulfate, 30 mg
sustained release morphine sulfate, 30 mg Code : 333 236-9 ; Access market authorisation 3400933323691
A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.
(Active Comparator)
Sustained release morphine sulfate, 30 mg
sustained release morphine sulfate, 30 mg Code : 333 236-9 ; Access market authorisation 3400933323691
A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.

Primary Outcomes

Measure
Morphine area under the curve (AUC0-inf) after its oral administration according to the morphine concentration.
time frame: During the study visit: morphine concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after its oral administration

Secondary Outcomes

Measure
Area under ther curve [AUC] of morphine-3-glucuronide, morphine-6-glucuronide
time frame: During the study visit: concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Time of the maximum plasma concentration [Tmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
time frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Observed clearance [Cl/F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
time frame: During the study visit: concentrations at time 0,5h; 1h; 1,5h; 2h; 2,5h; 3h; 4h; 5h; 6h; 8h; 12h after morphine oral administration
Observed Volume of distribution [Vd / F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
time frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Plasma Half-Life [T1 /2] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
time frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Maximum plasma concentration [Cmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
time frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

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

Additional Information

Official title Study of the Concentrations of Long Acting Morphine After Oral Absorption in Subjects Who Underwent Gastric Bypass (OBEMO 2)
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hopital Lariboisière.