Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-03 @ 9:10 AM
Study NCT ID:
NCT00943969
Status:
COMPLETED
Last Update Posted:
2015-12-16
First Post:
2009-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2009-07-21', 'studyFirstSubmitQcDate': '2009-07-21', 'lastUpdatePostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30mg Oral morphine systemic exposure (AUC 0-24)', 'timeFrame': 'Before surgery-7-15 days after surgery- 6 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Morphine and M6G AUC, clearance, Cmax and Tmax', 'timeFrame': 'Before surgery-7-15 days after surgery- 6 months after surgery'}, {'measure': 'fat mass and total body water (assessed by DEXA and BIA)', 'timeFrame': 'before surgery and 6 months following surgery'}, {'measure': 'mRNA and protein expression of P-gp , UGT2B7, MRP2 and MRP3 in intestinal biopsies', 'timeFrame': 'obtained from the bariatric surgery'}, {'measure': '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', 'timeFrame': 'Before surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'gastric bypass', 'morphine', 'pharmacokinetic', 'absorption'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 60 years old.\n* 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.\n* Patient agreeing to go 3 times for a one day hospitalisation in the URT of the Lariboisière Hospital for the morphine PK/PD.\n* Patient with a previous medical examination.\n* Patient giving its well-informed and free consent after information.\n\nExclusion Criteria:\n\n* diabetes\n* concomitant sedative, antidepressive or analgesic treatments or drugs unadvised with morphine\n* untreated sleep apnea syndrom, hypoxia (PaO2\\<70mmHg) or hypercapnia (PaCO2\\>45mmHg), anaemia \\<10g/dL, ASAT or ALAT\\>3N'}, 'identificationModule': {'nctId': 'NCT00943969', 'acronym': 'OBEMO', 'briefTitle': 'Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Lariboisière'}, 'officialTitle': 'Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass', 'orgStudyIdInfo': {'id': 'CPP 0911965'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'obemo', 'interventionNames': ['Procedure: gastric bypass']}], 'interventions': [{'name': 'gastric bypass', 'type': 'PROCEDURE', 'description': 'gastric bypass combines restrictive and malabsorptive procedures', 'armGroupLabels': ['obemo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Célia LLoret Linares', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Lariboisière', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MCU-PH', 'investigatorFullName': 'Célia LLORET LINARES', 'investigatorAffiliation': 'Hopital Lariboisière'}}}}