Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Drug: topiramate
  • modified-release capsules
• Drug: phentermine
  • immediate-release capsules
• Drug: topiramate
  • immediate-release tablets
• Drug: phentermine
  • immediate-release tablets

Primary Measures

• Pharmacokinetic parameters
  • Time Frame: One month
    

Inclusion Criteria:

• Obese adults
• Body mass index between 30.0 and 42.0 kg/m2 (inclusive)
• Medically healthy with no clinically significant results of screening exams

Exclusion Criteria:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
• History of glaucoma or increased intraocular pressure
• History of kidney stones
• Cholelithiasis or cholecystitis within 6 months
• Cardiovascular event within 6 months
• Obesity of known genetic or endocrine origin
• Recent weight instability
• Use of Very Low Calorie diet or participation in organized weight loss program within 3 months
• Systolic blood pressure > 150 or diastolic > 95 mm Hg
• Positive urine drug or alcohol screen
• Positive serology for HIV, HBV, or HCV
• History of alcoholism or drug abuse
• History of significant psychiatric disease, current depression of moderate or greater severity, any history of suicidal ideation
• Hypersensitivity to study drug or related compounds
• Use of prescription or OTC medication other than hormonal contraceptive within 14 days prior to first dosing with study drug
• Blood donation or significant blood loss within 56 days or plasma donation within 7 days prior to first dosing with study drug
• Women who are pregnant or lactating
• Hemoglobin < 12 g/dL
• Use of tobacco or nicotine-containing products within 6 months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: VIVUS, Inc.

Overall Clinical Trial Officials and Contacts

Charles H Bowden, MD Study Director VIVUS, Inc.  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00518466

Study ID Number: OB-102 / AA42851

ClinicalTrials.gov Identifier: NCT00518466

Health Authority: United States: Food and Drug Administration