The Effect of Betahistine on Body Weight in Obese Subjects

This study has been completed.
Sponsor:
Information provided by:
OBEcure Ltd.
ClinicalTrials.gov Identifier:
NCT00409305
First received: December 6, 2006
Last updated: August 3, 2007
Last verified: August 2007
  Purpose

The purpose of this study is to examine the effect that betahistine has on body weight in obese subjects.


Condition Intervention Phase
Obesity
Drug: Betahistine
Behavioral: Dietary counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight in Obese Subjects

Resource links provided by NLM:


Further study details as provided by OBEcure Ltd.:

Primary Outcome Measures:
  • To examine the effect of betahistine on body weight in obese subjects

Estimated Enrollment: 280
Study Start Date: January 2007
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed written informed consent;
  • Male or female subjects 18 to 65 years of age;
  • Is obese with a BMI greater than or equal to 30 kg/m2 to less than or equal to 40 kg/m2;
  • Has been obese for at least 1 year prior to screening; and
  • 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.

Exclusion Criteria:

  • Has obesity of known endocrine origin (e.g., Cushing's disease, Addison's disease, hypothalamic tumor);
  • 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);
  • Previous surgical procedures for weight loss;
  • Has had liposuction within 1 year before screening or is planning to have liposuction during the study;
  • History of bulimia or evidence of laxative abuse;
  • Has had a body weight loss of >4 kg in the 90 days prior to screening;
  • Has taken drugs capable of influencing body weight 30 days prior to screening;
  • Has recently started or plans on starting a smoking cessation program;
  • 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;
  • Is unwilling or unable to participate in a dietary program as part of the study;
  • Is <80% compliant with study medication in the single-blind placebo run-in period;
  • Has a clinically significant history or presence of any of the following conditions:
  • 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;
  • Liver disease (irrespective of transaminase concentrations);
  • Pheochromocytoma;
  • Porphyria;
  • Type 1 diabetes mellitus;
  • Type 2 diabetes mellitus on treatment other than metformin monotherapy and/or diet with HbA1c less than or equal to 8%;
  • Severe type 2 diabetes with history of ketoacidosis or diabetic ulcers, or presence of retinopathy, neuropathy, or nephropathy;
  • Renal insufficiency defined as a serum creatinine greater than or equal to 1.5 mg/dL (133 µmol/L) at screening;
  • Malignant disease within 5 years of screening;
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x ULN;
  • Thyroid-stimulating hormone (TSH) outside of the normal range;
  • Plans on having any surgery (elective or otherwise) during the course of the study;
  • 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%);
  • History of asthma;
  • History of peptic ulcers;
  • History of HIV;
  • History of undiagnosed allergy, severe allergy, or drug allergy, including history of anaphylaxis, angioedema, bronchospasm, or urticaria;
  • Has clinical laboratory test values (chemistry, hematology, or urinalysis) judged to be clinically significant by the investigator;
  • Has a physical examination or electrocardiogram (ECG) with significant abnormalities, as judged by the investigator;
  • 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;
  • Has hypersensitivity to betahistine;
  • 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);
  • Chronic or as needed use of antihistamines;
  • Has not been on a stable treatment regimen with any of the following medications for a minimum of 90 days prior to screening:
  • Hormone replacement therapy;
  • Oral contraceptives;
  • Antihypertensive agents;
  • Metformin;
  • Lipid-lowering agents; or
  • Thyroid replacement therapy;
  • 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;
  • All prescription or over-the-counter agents taken for the purpose of weight reduction, including (but not limited to) the following anti obesity agents:
  • Prescription drugs such as orlistat (Xenical), sibutramine (Meridia), and phentermine (Adipex-P, Celltech, Pro-Fast SA, Pro-Fast SR, Fastin, Oby trim, Zantryl, Teramine, Phentride, Phentercot, Obephen, Oby-cap); or
  • Over-the-counter antiobesity agents (e.g., herbal supplements or other alternative remedies such as Cortislim, Dexatrim, Acutrim);
  • Psychotropic/neurological agents including the following:
  • Antipsychotic agents (e.g., olanzapine, clozapine, risperidol, lithium, etc.).
  • Antiepileptic agents (e.g., Topamax®, Zonegran®, valproate, carbamazepine); or
  • 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.);
  • Systemic steroids administered by oral, intravenous, or intramuscular route;
  • 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);
  • Calcitonin (e.g., Miacalcin®);
  • Insulin;
  • Exenatide (Byetta®);
  • Sulfonylureas (e.g., Diamicron®, Amaryl®, Glucotrol®, Micronase®); or Meglitinides (e.g., Starlix®, Prandin®)
  • Has received any investigational drug within 90 days of screening;
  • Receipt of any investigational treatment (drug or device) within 90 days prior to screening;
  • 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
  • Is employed by OBEcure Ltd.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409305

Locations
United States, Alabama
Cahaba Research, Inc.
Birmingham, Alabama, United States, 35242
United States, California
Scripps Clinic, Nutrition Metabolic Research
San Diego, California, United States, 92130
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Florida
Miami Research Associates, Inc., Nutrition Division
Miami, Florida, United States, 33143
United States, Georgia
CSRA Partners in Health, Inc.
Augusta, Georgia, United States, 30909
United States, Illinois
Radiant Research, Inc.
Chicago, Illinois, United States, 60610
NCCR
Chicago, Illinois, United States, 60611
United States, Indiana
American Health Network
Indianapolis, Indiana, United States, 46254
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kansas
Radiant Research, Inc.
Overland Park, Kansas, United States, 66215
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
United States, Minnesota
Radiant Research, Inc.
Edina, Minnesota, United States, 55435
United States, Missouri
Diabetes & Endocrinology Specialists
Chesterfield, Missouri, United States, 63017
United States, New York
Comprehensive Weight Control Program
New York, New York, United States, 10021
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, Ohio
Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
United States, Oregon
Covance CRU, Inc.
Portland, Oregon, United States, 97239
United States, Texas
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
OBEcure Ltd.
Investigators
Principal Investigator: Andrew Ahmann, MD Covance CRU, Inc
Principal Investigator: Louis Aronne, MD Comprehensive Weight Control Program
Principal Investigator: Harold Bays, MD L-Marc Research Center
Principal Investigator: Norman Fishman, MD Diabetes & Endocrinology Specialists
Principal Investigator: Ken Fujioka, MD Scripps Clinic, Nutrition Metabolic Research
Study Director: Jeffrey Geohas, MD Radiant Research, Inc
Principal Investigator: Frank Greenway, MD Pennington Biodmedical Research Center
Principal Investigator: Dean Kereiakes, MD Lindner Clinical Trial Center
Principal Investigator: Diane Krieger, MD Miami Research Associates, Nutrition Division
Principal Investigator: Robert Kushner, MD NCCR
Principal Investigator: Thomas Moretto, MD American Health Network
Principal Investigator: Monica Pierson, MD Radiant Research
Principal Investigator: Sherwyn Schwartz, MD Diabetes & Glandular Disease Research Associates
Principal Investigator: Diane Smith, MD CSRA Partners in Health
Principal Investigator: Philip Toth, MD Midwest Institute for Clinical Research
Principal Investigator: Mervyn Weerasinghe, MD Rochester Clinical Research
Principal Investigator: Richard Weinstein, MD Diablo Clinical Research
Principal Investigator: Lisa Wright, MD Cahaba Research, Inc
Principal Investigator: James Zavoral, MD Radiant Research, Inc.
Study Director: Nir Barak, MD OBEcure Ltd.
Study Chair: Yaffa Beck, PhD OBEcure Ltd.
Study Chair: Ami Eyal, MD OBEcure Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00409305     History of Changes
Other Study ID Numbers: BET201
Study First Received: December 6, 2006
Last Updated: August 3, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Betahistine
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014