A Multicenter Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Topiramate in Weight Loss Maintenance in Obese Subjects Following Participation in an Intensive, Non-pharmacologic Weight Loss Program

University of Copenhagen1 site in 1 country701 target enrollmentAugust 2000

ConditionsObesity

InterventionsTopiramate 96 mg daily Topiramate 192 mg daily Placebo

DrugsTopiramate 96 mg daily Topiramate 192 mg daily Placebo

Overview

Phase: Phase 4
Intervention: Topiramate 96 mg daily
Conditions: Obesity
Sponsor: University of Copenhagen
Enrollment: 701
Locations: 1
Primary Endpoint: weight loss
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the efficacy and safety of topiramate (96 mg or 192 mg daily) as compared to placebo in maintaining weight loss in obese subjects who participated in an eight week intensive non-pharmacologic weight loss program.

The primary efficacy endpoint will be the percent change in body weight from enrollment visit to week 60.

Detailed Description

The study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. It was originally designed to last a total of 74 weeks: an 8 week non.pharmacologic low-calorie (800 to 1000 kcl/d) weight loss run-in phase, an 8 week titration phase, 52 week maintenance phase, and 6 week drug taper and follow up phase.

Registry

clinicaltrials.gov

Start Date

August 2000

End Date

June 2002

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Copenhagen

Responsible Party

Principal Investigator

Arne Astrup

ph.D, M.D.

University of Copenhagen

Eligibility Criteria

Inclusion Criteria

•Read and signed the informed consent form after the nature of the study has been fully explained
•18 to 75 years og age at enrollment
•subjects must have either:
•A body mass index BMI ≥ 33 kg/m\*m and \< 50 kg/m\*m, or
•A BMI ≥ 30 kg/m\*m \< 50 kg/m\*m if any of the following established co-morbidities are present:
•Controlled hypertension or dyslipidemia. Anti-hypertensive and hypo-lipidemic medication should have been at a stable dose for at least two months prior to enrollment. If subjects are clinically diagnosed with any of these conditions as a result of enrollment assessments, they can only continue in the enrollment phase if in the clinical judgment of the investigator initiation of anti-hypertensive or hypo-lipidemic therapy is not required.
•Subjects diagnosed with type 2 diabetes by means of OGTT at enrollment visit and not requiring anti diabetic therapy according to the clinical judgement of the investigator.
•Stable weight (varying to more than 3 kg) for at least 3 months prior to enrollment.
•Female subjects must be post menopausal for at least a year or surgically incapable of childbearing, practicing abstinence an acceptable method of birth control. If a female subject of child bearing potential is practicing an acceptable method of birth control, she must have had a negative urine pregnancy test at enrollment, as well as at baseline, prior to receiving study drug.
•Randomization criteria

Exclusion Criteria

•Subjects who meet any of the following criteria will be excluded from participating in the study.
•Prior exposure or known contraindication or hypersensitivity to topiramate;
•Exposure to any other experimental drug or device within 30 days prior to enrollment;
•Pregnancy or nursing or subjects who plan to become pregnant during the study;
•An established diagnosis of diabetes prior to study enrollment;
•History or evidence of clinically significant hepatic disease;
•Evidence of renal impairment;
•Significant cardiovascular disease;
•Uncontrolled hypertension 180 / 100 mmHg
•Hypertensive subjects on medications must have been on the same dose of the same hypertensive medication for at least 2 months;