Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass (OBEMO)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Hopital Lariboisière.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hopital Lariboisière
Information provided by:
Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT00943969
First received: July 21, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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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 4 |
| 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
Drug Information available for:
Morphine sulfate
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 May 16, 2013