Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-04-21 @ 1:52 PM
Study NCT ID:
NCT02706067
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2016-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-09-23', 'releaseDate': '2016-08-03'}], 'estimatedResultsFirstSubmitDate': '2016-08-03'}}, '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': 'D000077403', 'term': 'Orlistat'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-02', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-03-08', 'lastUpdatePostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Weight at Year 2', 'timeFrame': 'Baseline and Year 2'}, {'measure': 'Percent Change from Baseline in Body Weight at Year 4', 'timeFrame': 'Baseline and Year 4'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria', 'timeFrame': 'Every 6 months during Year 1, annually during Years 2 to 4'}, {'measure': 'Eating Disorder Inventory (EDI) 2 Subscale and Total Score', 'timeFrame': 'Baseline and Year 4'}, {'measure': 'Hospital Anxiety and Depression (HAD) Subscale Score', 'timeFrame': 'Baseline and Year 4'}, {'measure': 'Number of Orlistat Capsules Taken During the Study', 'timeFrame': 'Given up to three times per day for 4 years'}, {'measure': 'Duration of Orlistat Treatment During the Study', 'timeFrame': 'Given up to three times per day for 4 years'}, {'measure': 'Waist-to-Hip Circumference Ratio', 'timeFrame': 'Baseline and Year 4'}, {'measure': 'Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters)', 'timeFrame': 'Baseline and Year 4'}, {'measure': 'Skinfold Thickness (Expressed in Millimeters)', 'timeFrame': 'Baseline and Year 4'}, {'measure': 'Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass)', 'timeFrame': 'Baseline and Year 4'}, {'measure': 'Number of Kilocalories Expended, Total and at Rest', 'timeFrame': 'Baseline and Year 4'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) greater than or equal to (\\>/=) 30 kilograms per meter-squared (kg/m\\^2), or BMI \\>/= 28 kg/m\\^2 with risk factors of diabetes, hypertension, or hyperlipidemia, before weight loss\n* Documented weight loss \\>/= 10% of initial body weight obtained with diet, with or without psychological therapy or orlistat\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* History or presence of significant medical disorders\n* Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes\n* Pancreatic disease: pancreatic enzyme deficiency, history or current presence of pancreatitis\n* Clinically significant abnormal clinical chemistry or hematology results\n* Excessive alcohol intake\n* Smoking cessation within the previous 6 months\n* History or presence of cancer\n* Administration of medicines known to alter body weight\n* History or presence of cancer'}, 'identificationModule': {'nctId': 'NCT02706067', 'briefTitle': 'Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Patients', 'orgStudyIdInfo': {'id': 'ML16868'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orlistat', 'description': 'Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes.', 'interventionNames': ['Drug: Orlistat']}], 'interventions': [{'name': 'Orlistat', 'type': 'DRUG', 'otherNames': ['Xenical'], 'description': 'Participants will receive orlistat on an intermittent basis as 120 milligrams (mg) three times a day: once with breakfast, once with lunch, and once with dinner. In case of weight relapse (increase 2.5 percent \\[%\\] or more from Baseline) orlistat will be administered for up to 2 months or until weight regain reaches 0% from Baseline. For special occasions (feasts, birthdays, anniversaries) orlistat will be given for up to 3 days.', 'armGroupLabels': ['Orlistat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-08-03', 'type': 'RELEASE'}, {'date': '2016-09-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hoffmann-La Roche'}}}}