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ObesityPhase 2NCT00236613

A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

A Phase 2 study testing topiramate in people with Obesity, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity
What is being tested?
topiramate
How many people
385 participants
Where
No sites listed yet
Study dates
Sep 2000to Jul 2001
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

About this study

Official title: 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

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.

Read the detailed description

Topiramate is not approved for the treatment of obesity. This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and effectiveness of topiramate in treatment of obese patients. Patients will receive 24 weeks of treatment by topiramate or placebo, followed by 2 week taper and a safety follow-up. Effectiveness will be determined by changes from baseline to week 24 in body weight, body mass index (BMI), anthropometric measurements (waist circumference, hip circumference, waist/hip ration), fasting lipid profiles, fasting plasma glucose, HbA1c (shows average blood sugar level over months), fasting uric acid, fasting insulin, and blood pressures. Safety evaluations (incidence of adverse events, physical examinations, 12 lead ECGs, vital signs, Computerized Neuropsychological Test Battery) will be performed throughout the study. The study hypothesis is that topiramate will be effective in achieving and maintaining weight reduction in obese patients and is well tolerated. The patients will be randomized to receive either topiramate (64, 96, 192, or 384 mg daily) or placebo daily by mouth for 24 weeks.

Conditions
Obesity
Being tested
topiramate
Keywords
Obesity, Hypertension, Hyperlipidemia, Body Mass Index
Medical subject headings
Obesity, Hypertension, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • topiramateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percent change in body weight from baseline (at the time of randomization) to Week 24.

Secondary outcomes (1)

  1. Changes from baseline to week 24 in total body weight, body mass index, fasting plasma glucose; incidence of adverse events over study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2005 (estimated)
  2. Study startSep 2000
  3. Study completionJul 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00236613
Sponsor's protocol ID
CR003709
Status last verified
Dec 2010
First submitted
7 Oct 2005
Last updated
3 Dec 2010
Results posted
No

Publications

  • 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.

    PubMed 12805393

  • Loring 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.

    PubMed 21148119

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing topiramate in people with Obesity, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percent change in body weight from baseline (at the time of randomization) to Week 24.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00236613, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2010.

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