Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT00409305
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2006-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Betahistine on Body Weight in Obese Subjects
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': 'D001621', 'term': 'Betahistine'}, {'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-20', 'studyFirstSubmitDate': '2006-12-06', 'studyFirstSubmitQcDate': '2006-12-06', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine the effect of betahistine on body weight in obese subjects'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect that betahistine has on body weight in obese subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed written informed consent;\n* Male or female subjects 18 to 65 years of age;\n* Is obese with a BMI greater than or equal to 30 kg/m2 to less than or equal to 40 kg/m2;\n* Has been obese for at least 1 year prior to screening; and\n* If female, is nonlactating, has a negative urine pregnancy test result, and does not plan on becoming pregnant during the study, or not of childbearing potential (hysterectomy or tubal ligation at least 6 months prior to randomization or post-menopausal for 1 year); if of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must practice or be willing to continue to practice appropriate birth control (such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire study duration.\n\nExclusion Criteria:\n\n* Has obesity of known endocrine origin (e.g., Cushing's disease, Addison's disease, hypothalamic tumor);\n* Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics (e.g., polydactyly) suggestive of genetic obesity (e.g., ob/ob genotype) or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet Biedl syndrome);\n* Previous surgical procedures for weight loss;\n* Has had liposuction within 1 year before screening or is planning to have liposuction during the study;\n* History of bulimia or evidence of laxative abuse;\n* Has had a body weight loss of \\>4 kg in the 90 days prior to screening;\n* Has taken drugs capable of influencing body weight 30 days prior to screening;\n* Has recently started or plans on starting a smoking cessation program;\n* Has had a major change in daily physical activity (e.g., initiation of an exercise program) or started a weight loss program within 90 days prior to screening;\n* Is unwilling or unable to participate in a dietary program as part of the study;\n* Is \\<80% compliant with study medication in the single-blind placebo run-in period;\n* Has a clinically significant history or presence of any of the following conditions:\n* Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;\n* Liver disease (irrespective of transaminase concentrations);\n* Pheochromocytoma;\n* Porphyria;\n* Type 1 diabetes mellitus;\n* Type 2 diabetes mellitus on treatment other than metformin monotherapy and/or diet with HbA1c less than or equal to 8%;\n* Severe type 2 diabetes with history of ketoacidosis or diabetic ulcers, or presence of retinopathy, neuropathy, or nephropathy;\n* Renal insufficiency defined as a serum creatinine greater than or equal to 1.5 mg/dL (133 µmol/L) at screening;\n* Malignant disease within 5 years of screening;\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2 x ULN;\n* Thyroid-stimulating hormone (TSH) outside of the normal range;\n* Plans on having any surgery (elective or otherwise) during the course of the study;\n* Has uncontrolled hypertension (sitting blood pressure \\>160/95 mmHg at screening or randomization), uncontrolled hyperlipidemia (triglycerides \\[TG\\] greater than or equal to 400 mg/dL or low-density lipoprotein cholesterol \\[LDL-C\\] \\>160 mg/dL), or uncontrolled diabetes (HbA1c \\>8%);\n* History of asthma;\n* History of peptic ulcers;\n* History of HIV;\n* History of undiagnosed allergy, severe allergy, or drug allergy, including history of anaphylaxis, angioedema, bronchospasm, or urticaria;\n* Has clinical laboratory test values (chemistry, hematology, or urinalysis) judged to be clinically significant by the investigator;\n* Has a physical examination or electrocardiogram (ECG) with significant abnormalities, as judged by the investigator;\n* Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion could cause the subject to be noncompliant with study procedures;\n* Has hypersensitivity to betahistine;\n* Has psychiatric or neurological disorders requiring chronic medications (e.g., antidepressants), subjects are to be unlikely to have a major depressive episode (score of lees than or equal to 8) on The Harvard Department of Psychiatry and National Depression Screening Day Scale (THE HANDS) (See Appendix E);\n* Chronic or as needed use of antihistamines;\n* Has not been on a stable treatment regimen with any of the following medications for a minimum of 90 days prior to screening:\n* Hormone replacement therapy;\n* Oral contraceptives;\n* Antihypertensive agents;\n* Metformin;\n* Lipid-lowering agents; or\n* Thyroid replacement therapy;\n* Has been treated over the past 60 days, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications;\n* All prescription or over-the-counter agents taken for the purpose of weight reduction, including (but not limited to) the following anti obesity agents:\n* Prescription drugs such as orlistat, sibutramine, and phentermine; or\n* Over-the-counter antiobesity agents (e.g., herbal supplements or other alternative remedies such as Cortislim, Dexatrim, Acutrim);\n* Psychotropic/neurological agents including the following:\n* Antipsychotic agents (e.g., olanzapine, clozapine, risperidol, lithium, etc.).\n* Antiepileptic agents (e.g., Topamax®, Zonegran®, valproate, carbamazepine); or\n* Antidepressant agents including the following: monoamine oxidase inhibitors, bupropion (Wellbutrin®, Zyban®), tricyclic antidepressants, and tetracyclic antidepressants; and selective serotonin reuptake inhibitors (e.g., Prozac®, Paxil®, Zoloft®, etc.);\n* Systemic steroids administered by oral, intravenous, or intramuscular route;\n* Drugs that directly affect gastrointestinal motility (e.g., Reglan® and Propulsid®, and chronic \\[taken for more than 10 days within a 6-month period\\] macrolide antibiotics such as erythromycin and newer derivatives);\n* Calcitonin (e.g., Miacalcin®);\n* Insulin;\n* Exenatide (Byetta);\n* Sulfonylureas (e.g., Diamicron, Amaryl, Glucotrol, Micronase); or Meglitinides (e.g., Starlix, Prandin)\n* Has received any investigational drug within 90 days of screening;\n* Receipt of any investigational treatment (drug or device) within 90 days prior to screening;\n* Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site; or\n* Is employed by OBEcure Ltd."}, 'identificationModule': {'nctId': 'NCT00409305', 'briefTitle': 'The Effect of Betahistine on Body Weight in Obese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'OBEcure Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight in Obese Subjects', 'orgStudyIdInfo': {'id': 'BET201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Betahistine', 'type': 'DRUG'}, {'name': 'Dietary counseling', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Research, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92130', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic, Nutrition Metabolic Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates, Inc., Nutrition Division', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'CSRA Partners in Health, Inc.', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'NCCR', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46254', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'American Health Network', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Institute for Clinical Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'L-MARC Research Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Diabetes & Endocrinology Specialists', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Comprehensive Weight Control Program', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lindner Clinical Trial Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Covance CRU, Inc.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes & Glandular Disease Research Associates, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Andrew Ahmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance CRU, Inc'}, {'name': 'Louis Aronne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Comprehensive Weight Control Program'}, {'name': 'Harold Bays, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'L-Marc Research Center'}, {'name': 'Norman Fishman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabetes & Endocrinology Specialists'}, {'name': 'Ken Fujioka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Clinic, Nutrition Metabolic Research'}, {'name': 'Jeffrey Geohas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research, Inc'}, {'name': 'Frank Greenway, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biodmedical Research Center'}, {'name': 'Dean Kereiakes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lindner Clinical Trial Center'}, {'name': 'Diane Krieger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miami Research Associates, Nutrition Division'}, {'name': 'Robert Kushner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCCR'}, {'name': 'Thomas Moretto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Health Network'}, {'name': 'Monica Pierson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiant Research'}, {'name': 'Sherwyn Schwartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabetes & Glandular Disease Research Associates'}, {'name': 'Diane Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSRA Partners in Health'}, {'name': 'Philip Toth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Midwest Institute for Clinical Research'}, {'name': 'Mervyn Weerasinghe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rochester Clinical Research'}, {'name': 'Richard Weinstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diablo Clinical Research'}, {'name': 'Lisa Wright, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cahaba Research, Inc'}, {'name': 'James Zavoral, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiant Research, Inc.'}, {'name': 'Nir Barak, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'OBEcure Ltd.'}, {'name': 'Yaffa Beck, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'OBEcure Ltd.'}, {'name': 'Ami Eyal, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'OBEcure Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OBEcure Ltd.', 'class': 'INDUSTRY'}}}}