Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass - Full Text View

Sponsor:	Hopital Lariboisière
Information provided by:	Hopital Lariboisière
ClinicalTrials.gov Identifier:	NCT00943969

Purpose

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.

Condition	Intervention	Phase
Obesity	Procedure: gastric bypass	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Hopital Lariboisière:

Primary Outcome Measures:

30mg Oral morphine systemic exposure (AUC 0-24) [ Time Frame: Before surgery-7-15 days after surgery- 6 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Morphine and M6G AUC, clearance, Cmax and Tmax [ Time Frame: Before surgery-7-15 days after surgery- 6 months after surgery ] [ Designated as safety issue: No ]
fat mass and total body water (assessed by DEXA and BIA) [ Time Frame: before surgery and 6 months following surgery ] [ Designated as safety issue: No ]
mRNA and protein expression of P-gp , UGT2B7, MRP2 and MRP3 in intestinal biopsies [ Time Frame: obtained from the bariatric surgery ] [ Designated as safety issue: No ]
genetic polymorphisms known to affect expression and/or activity of enzymes, receptors and transporters involved in morphine PK/PD (UGT2B7, P-gp, OPRM1, COMT) and morphine PK/PD [ Time Frame: Before surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2009
Estimated Study Completion Date:	September 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
obemo	Procedure: gastric bypass gastric bypass combines restrictive and malabsorptive procedures

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943969

Contacts

Contact: Célia Lloret Linares, MD

00 33 1 49 95 65 19

celialloret@yahoo.fr

Locations

France
Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital	Recruiting
Paris cedex 10, France, 75475
Contact: Célia Lloret Linares, MD

Sponsors and Collaborators

Hopital Lariboisière

Investigators

Principal Investigator:

Célia LLoret Linares

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Célia Lloret Linares, Unit of Therapeutic Research, Department of Internal Medicine, Hopital Lariboisière
ClinicalTrials.gov Identifier:	NCT00943969 History of Changes
Other Study ID Numbers:	CPP 0911965
Study First Received:	July 21, 2009
Last Updated:	July 21, 2009
Health Authority:	France: Ministry of Health

Keywords provided by Hopital Lariboisière:

obesity
gastric bypass
morphine
pharmacokinetic
absorption

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Morphine
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012