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

November 28, 2016 updated by: Célia Lloret-Linares, MD PhD, Hopital Lariboisière

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Hopital Pitie Salpetriere
      • Paris, France, 75010
        • Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboisiere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects Roux-en-Y-gastric bypass (RYGB)
Sustained release morphine sulfate, 30 mg
Drug: Sustained release morphine sulfate, 30 mg
A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.
Other Names:
  • Code : 333 236-9 ; Access market authorisation 3400933323691
Active Comparator: Control volunteers matched with RYGB
Sustained release morphine sulfate, 30 mg
Drug: Sustained release morphine sulfate, 30 mg
A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.
Other Names:
  • Code : 333 236-9 ; Access market authorisation 3400933323691

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
Blood samples gathered from hour 0,5 to hour 12 and urine sample gathered from the start to the end of the study visit.
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Lariboisière

Investigators

  • Study Director: Jean-Francois JB Bergmann, MD, PhD, Hôpital Lariboisière

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

December 28, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBEMO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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