ObesityPhase 3NCT00236600
A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program
A Phase 3 study testing topiramate in people with Obesity, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to compare the efficacy and safety of topiramate 96mg and 192mg daily) with placebo in the treatment of obesity following an intensive non-pharmacologic weight loss program. 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
- 561 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Jun 2002
- Phase
- Phase 3
- 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) >= 33 and < 50 kg/m2
- BMI >=30 and < 50 kg/m2 if patients have 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)
- Randomization criteria: Weight reduction of more than 8% of enrollment body weight during the eight week run-in phase
Who cannot join
- Prior exposure, known contraindication, or hypersensitivity to topiramate
- Exposure to any other experimental drug or device within last 30 days
- A diagnosis of diabetes (except those diagnosed during the enrollment if no medications are needed)
- 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
Show all 9Show fewer
- History of weight loss surgery or liposuction
- History of malignancy within last 5 years
- History of an eating disorder
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Efficacy and Safety of Topiramate in Weight Loss Maintenance in Obese Patients Following Participation in an Intensive, Non-Pharmacologic Weight Loss Program
The purpose of this study is to compare the efficacy and safety of topiramate 96mg and 192mg daily) with placebo in the treatment of obesity following an intensive non-pharmacologic weight loss program.
Read the detailed description
Although dietary modification coupled with increased exercise is the preferred treatment of obesity, these lifestyle changes alone are often insufficient in achieving and maintaining weight reduction in obese patients. Topiramate is not approved for the treatment of obesity. This double-blind, placebo controlled study will evaluate the effectiveness and safety of topiramate in maintaining weight loss achieved by an intensive non-drug weight reduction program. Enrolled patients will undergo run-in phase (8 weeks of intensive non-drug weight reduction therapy consisting of a low calorie diet, a behavioral modification program, and an exercise program). Those patients who achieve weight loss of >= 8% of enrollment body weight and meeting the eligibility criteria will be randomized to either 96mg or 192mg of topiramate, or placebo. After 8 weeks of dose titration, the patients will receive one year of treatment. Effectiveness will be assessed by body weight, Body Mass Index (BMI), number and proportion of 5%, 10% and 15% weight loss responders, number and proportion of patients who maintain 50%, 75%, and 100% of weight lost during run-in phase, waist and hip circumferences, fasting lipid profile, fasting plasma glucose, HbA1c, fasting insulin, two-hour glucose tolerance test, uric acid level, blood pressure, body composition, echocardiography, and Health Related Quality of Life scores. Safety evaluations (incidence of adverse events, electrocardiograms, vital signs, etc) will be performed throughout the study. The study hypothesis is that topiramate is more effective than placebo in maintaining weight reduction in obese patients following intensive non-drug weight reduction program. During the initial 8 weeks, the doses of topiramate or placebo will be gradually increased to the target doses (either 96mg or 192mg) daily by mouth and the doses will be maintained for one year.
- Conditions
- Obesity
- Being tested
- topiramate
- Keywords
- Obesity, Hypertension, Hyperlipidemia, Type 2 Diabetes, Life style modification
- Medical subject headings
- Obesity, Hypertension, Hyperlipidemias, Diabetes Mellitus, Type 2
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.
The percent change in body weight from the enrollment visit to week 60.
Secondary outcomes (1)
Change from baseline to week 60 in absolute change in body weight, body mass index, waist circumference, fasting lipid profile; safety evaluations over study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startAug 2000
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236600
- Sponsor's protocol ID
- CR003706
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 2005
- Last updated
- 28 Apr 2010
- Results posted
- No
Publications
Astrup A, Caterson I, Zelissen P, Guy-Grand B, Carruba M, Levy B, Sun X, Fitchet M. Topiramate: long-term maintenance of weight loss induced by a low-calorie diet in obese subjects. Obes Res. 2004 Oct;12(10):1658-69. doi: 10.1038/oby.2004.206.
PubMed 15536230
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Efficacy and Safety of Topiramate in Weight Loss Maintenance in Obese Patients Following Participation in an Intensive, Non-Pharmacologic Weight Loss Program
- ClinicalTrials.gov ID
- NCT00236600
- Acronym / sponsor ID
- CR003706
- Conditions
- Obesity
- Keywords
- Obesity, Hypertension, Hyperlipidemia, Type 2 Diabetes, Life style modification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Aug 2000
- Study completion
- Jun 2002 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of topiramate 96mg and 192mg daily) with placebo in the treatment of obesity following an intensive non-pharmacologic weight loss program.
Detailed description
Although dietary modification coupled with increased exercise is the preferred treatment of obesity, these lifestyle changes alone are often insufficient in achieving and maintaining weight reduction in obese patients. Topiramate is not approved for the treatment of obesity. This double-blind, placebo controlled study will evaluate the effectiveness and safety of topiramate in maintaining weight loss achieved by an intensive non-drug weight reduction program. Enrolled patients will undergo run-in phase (8 weeks of intensive non-drug weight reduction therapy consisting of a low calorie diet, a behavioral modification program, and an exercise program). Those patients who achieve weight loss of >= 8% of enrollment body weight and meeting the eligibility criteria will be randomized to either 96mg or 192mg of topiramate, or placebo. After 8 weeks of dose titration, the patients will receive one year of treatment. Effectiveness will be assessed by body weight, Body Mass Index (BMI), number and proportion of 5%, 10% and 15% weight loss responders, number and proportion of patients who maintain 50%, 75%, and 100% of weight lost during run-in phase, waist and hip circumferences, fasting lipid profile, fasting plasma glucose, HbA1c, fasting insulin, two-hour glucose tolerance test, uric acid level, blood pressure, body composition, echocardiography, and Health Related Quality of Life scores. Safety evaluations (incidence of adverse events, electrocardiograms, vital signs, etc) will be performed throughout the study. The study hypothesis is that topiramate is more effective than placebo in maintaining weight reduction in obese patients following intensive non-drug weight reduction program. During the initial 8 weeks, the doses of topiramate or placebo will be gradually increased to the target doses (either 96mg or 192mg) daily by mouth and the doses will be maintained for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) >= 33 and < 50 kg/m2
- BMI >=30 and < 50 kg/m2 if patients have 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)
- Randomization criteria: Weight reduction of more than 8% of enrollment body weight during the eight week run-in phase
Key exclusion criteria (9 listed)
- Prior exposure, known contraindication, or hypersensitivity to topiramate
- Exposure to any other experimental drug or device within last 30 days
- A diagnosis of diabetes (except those diagnosed during the enrollment if no medications are needed)
- History or evidence of clinically significant liver disease, cardiovascular disease, uncontrolled hypertension or high thyroid levels
- History of obesity with known cause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topiramate | Drug | – |
Primary outcome
The percent change in body weight from the enrollment visit to week 60.
1 secondary outcome
Change from baseline to week 60 in absolute change in body weight, body mass index, waist circumference, fasting lipid profile; safety evaluations over study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
- Results publication: PubMed 15536230Astrup A, Caterson I, Zelissen P, Guy-Grand B, Carruba M, Levy B, Sun X, Fitchet M. Topiramate: long-term maintenance of weight loss induced by a low-calorie diet in obese subjects. Obes Res. 2004 Oct;12(10):1658-69. doi: 10.1038/oby.2004.206.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 5 inclusion and 9 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 28 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 the enrollment visit to week 60.. 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 NCT00236600, which also lists 1 linked publication.
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 28 Apr 2010.