Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT00518466
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2007-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
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': 'D000077236', 'term': 'Topiramate'}, {'id': 'D010645', 'term': 'Phentermine'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2007-08-16', 'studyFirstSubmitQcDate': '2007-08-16', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters', 'timeFrame': 'One month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese adults\n* Body mass index between 30.0 and 42.0 kg/m2 (inclusive)\n* Medically healthy with no clinically significant results of screening exams\n\nExclusion Criteria:\n\n* History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease\n* History of glaucoma or increased intraocular pressure\n* History of kidney stones\n* Cholelithiasis or cholecystitis within 6 months\n* Cardiovascular event within 6 months\n* Obesity of known genetic or endocrine origin\n* Recent weight instability\n* Use of Very Low Calorie diet or participation in organized weight loss program within 3 months\n* Systolic blood pressure \\> 150 or diastolic \\> 95 mm Hg\n* Positive urine drug or alcohol screen\n* Positive serology for HIV, HBV, or HCV\n* History of alcoholism or drug abuse\n* History of significant psychiatric disease, current depression of moderate or greater severity, any history of suicidal ideation\n* Hypersensitivity to study drug or related compounds\n* Use of prescription or OTC medication other than hormonal contraceptive within 14 days prior to first dosing with study drug\n* Blood donation or significant blood loss within 56 days or plasma donation within 7 days prior to first dosing with study drug\n* Women who are pregnant or lactating\n* Hemoglobin \\< 12 g/dL\n* Use of tobacco or nicotine-containing products within 6 months'}, 'identificationModule': {'nctId': 'NCT00518466', 'briefTitle': 'Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIVUS LLC'}, 'officialTitle': 'A Phase Ib, Open Label, Parallel-Design Single- and Multiple-Dose Study Comparing Modified Release Topiramate Formulations to Immediate Release Formulations of Topiramate Dosed in Combination With Immediate Release Phentermine in Obese Adults', 'orgStudyIdInfo': {'id': 'OB-102 / AA42851'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment 1', 'description': 'One 7.5 mg phentermine hydrochloride IR capsule and two 25 mg topiramate MR capsules at Hour 0 on Day 1 of Period 1.\n\nOne 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate MR capsule at Hour 0 on Days 1, 2, and 3 of Period 2.\n\nOne 7.5 mg phentermine hydrochloride IR capsule and two 25 mg topiramate MR capsules at Hour 0 on Days 4 - 21 of Period 2.', 'interventionNames': ['Drug: topiramate', 'Drug: phentermine']}, {'type': 'EXPERIMENTAL', 'label': 'treatment 2', 'description': 'Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Day 1 of Period 1.\n\nOne 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate MR capsule at Hour 0 on Days 1, 2, and 3 of Period 2.\n\nOne 7.5 mg phentermine hydrochloride IR capsules and two 25 mg topiramate MR capsules at Hour 0 on Days 4, 5, and 6 of Period 2.\n\nTwo 7.5 mg phentermine hydrochloride IR capsules (Cardinal) and three 25 mg topiramate MR capsules at Hour 0 on Days 7, 8, and 9 of Period 2.\n\nTwo 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Days 10 - 21 of Period 2.', 'interventionNames': ['Drug: topiramate', 'Drug: phentermine']}, {'type': 'EXPERIMENTAL', 'label': 'treatment 3', 'description': 'Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Day 1 of Period 1.\n\nOne 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate MR capsule at Hour 0 on Days 1, 2, and 3 of Period 2.\n\nTwo 7.5 mg phentermine hydrochloride IR capsules and two 25 mg topiramate MR capsule at Hour 0 on Days 4, 5, and 6 of Period 2.\n\nTwo 7.5 mg phentermine hydrochloride IR capsules and three 25 mg topiramate MR capsules at Hour 0 on Days 7, 8, and 9 of Period 2.\n\nTwo 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Days 10 - 21 of Period 2.', 'interventionNames': ['Drug: topiramate', 'Drug: phentermine']}, {'type': 'EXPERIMENTAL', 'label': 'treatment 4', 'description': 'Half of a 37.5 mg phentermine hydrochloride IR tablet and one 100 mg topiramate IR tablet at Hour 0 on Day 1 of Period 1.\n\nOne 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate IR tablet at Hour 0 on Days 1, 2, and 3 of Period 2.\n\nHalf of a 37.5 mg phentermine hydrochloride IR tablet and two 25 mg topiramate IR tablets at Hour 0 on Days 4, 5, and 6 of Period 2.\n\nHalf of a 37.5 mg phentermine hydrochloride IR tablet and three 25 mg topiramate IR tablets at Hour 0 on Days 7, 8, and 9 of Period 2.\n\nHalf of a 37.5 mg phentermine hydrochloride IR tablet and one 100 mg topiramate IR tablet at Hour 0 on Days 10 - 21 of Period 2.', 'interventionNames': ['Drug: topiramate', 'Drug: phentermine']}], 'interventions': [{'name': 'topiramate', 'type': 'DRUG', 'description': '25 mg modified-release capsules', 'armGroupLabels': ['treatment 1', 'treatment 2', 'treatment 3']}, {'name': 'phentermine', 'type': 'DRUG', 'description': '7.5 mg immediate-release capsules', 'armGroupLabels': ['treatment 1', 'treatment 2', 'treatment 3']}, {'name': 'topiramate', 'type': 'DRUG', 'description': '100 and 25 mg immediate-release tablets', 'armGroupLabels': ['treatment 4']}, {'name': 'phentermine', 'type': 'DRUG', 'description': '37.5 and 7.5 mg immediate-release tablets', 'armGroupLabels': ['treatment 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'VIVUS, Inc.', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'overallOfficials': [{'name': 'Wesley W Day, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VIVUS LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIVUS LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wesley Day, VP Clinical', 'oldOrganization': 'Vivus, Inc.'}}}}