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Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass

NCT ID: NCT00943969

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-01-31

Brief Summary

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The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Different data suggest that this surgery may modify drug absorption and we think it would be clinically relevant to describe the consequences of gastric bypass on drug systemic exposure in obese patients, since no data on the comparison between the pharmacokinetics (PK) of a drug before and after surgery are available and help to predict the drugs posology.The investigators decided to study the morphine because there is a lack of information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range frequently prescribed in obese patients.

Detailed Description

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Conditions

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Obesity

Keywords

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obesity gastric bypass morphine pharmacokinetic absorption

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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obemo

Group Type OTHER

gastric bypass

Intervention Type PROCEDURE

gastric bypass combines restrictive and malabsorptive procedures

Interventions

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gastric bypass

gastric bypass combines restrictive and malabsorptive procedures

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients aged between 18 and 60 years old.
* Patients with morbid obesity (IMC \> 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension or steatosis hepatitis) with a favourable decision of a multidisciplinary team for a gastric bypass.
* Patient agreeing to go 3 times for a one day hospitalisation in the URT of the Lariboisière Hospital for the morphine PK/PD.
* Patient with a previous medical examination.
* Patient giving its well-informed and free consent after information.

Exclusion Criteria

* diabetes
* concomitant sedative, antidepressive or analgesic treatments or drugs unadvised with morphine
* untreated sleep apnea syndrom, hypoxia (PaO2\<70mmHg) or hypercapnia (PaCO2\>45mmHg), anaemia \<10g/dL, ASAT or ALAT\>3N
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hopital Lariboisière

OTHER

Sponsor Role lead

Responsible Party

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Célia LLORET LINARES

MCU-PH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Célia LLoret Linares

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CPP 0911965

Identifier Type: -

Identifier Source: org_study_id