MedTrace Logo

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

NCT02641301 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-11-29

No results posted yet for this study

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.

Conditions

  • Bypass Complications

Interventions

DRUG

Sustained release morphine sulfate, 30 mg

A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.

Sponsors & Collaborators

  • Hopital Lariboisière

    lead OTHER

Principal Investigators

  • Jean-Francois JB Bergmann, MD, PhD · Hopital Lariboisiere

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02641301 on ClinicalTrials.gov