A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Dose-Response Study to Assess the Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity
1 other identifier
interventional
385
0 countries
N/A
Brief Summary
The purpose of this study is to compare the safety and effectiveness of topiramate (64mg, 96mg, 192mg, and 384mg daily) with placebo in the treatment of obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Sep 2000
Shorter than P25 for phase_2 obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedDecember 3, 2010
December 1, 2010
October 7, 2005
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The percent change in body weight from baseline (at the time of randomization) to Week 24.
Secondary Outcomes (1)
Changes from baseline to week 24 in total body weight, body mass index, fasting plasma glucose; incidence of adverse events over study.
Interventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) \>=30 and \<50
- BMI \>= 27 and \< 50 if patient has controlled hypertension or abnormal blood lipids
- Stable weight
- Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
You may not qualify if:
- Known contraindication, or hypersensitivity to topiramate
- Exposure to any other experimental drug or device within last 30 days
- A diagnosis of diabetes
- History or evidence of clinically significant liver disease, cardiovascular disease, uncontrolled hypertension or high thyroid levels
- History of obesity with known cause
- History or family history of kidney stones
- History of weight loss surgery
- History of malignancy within last 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Bray GA, Hollander P, Klein S, Kushner R, Levy B, Fitchet M, Perry BH. A 6-month randomized, placebo-controlled, dose-ranging trial of topiramate for weight loss in obesity. Obes Res. 2003 Jun;11(6):722-33. doi: 10.1038/oby.2003.102.
PMID: 12805393RESULTLoring DW, Williamson DJ, Meador KJ, Wiegand F, Hulihan J. Topiramate dose effects on cognition: a randomized double-blind study. Neurology. 2011 Jan 11;76(2):131-7. doi: 10.1212/WNL.0b013e318206ca02. Epub 2010 Dec 9.
PMID: 21148119DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
September 1, 2000
Study Completion
July 1, 2001
Last Updated
December 3, 2010
Record last verified: 2010-12