A Phase 3 interventional study of topiramate in Obesity, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-04-28.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the efficacy and safety of topiramate (96, 192, and 256mg daily) with placebo in long-term treatment of obesity.
Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study assesses long-term effectiveness and safety of topiramate in patients with obesity. After completing 6 weeks of run-in phase (a single-blind placebo-treatment phase during which patients begin non-pharmacological therapy), patients will be randomized to receive either topiramate or placebo. Topiramate group will receive 16mg of topiramate and the dose will be titrated over 8 weeks. Patients will then receive two years of treatment. Effectiveness will be evaluated by body weight, Body Mass Index (BMI), anthropometric measurements (waist circumference, hip circumference, waist/hip ratio), fasting lipid profile, fasting plasma glucose, HbA1c, fasting uric acid, fasting insulin, blood pressures, body fat compositions, mass of left ventricle of the heart (as measured by echocardiography), and Health Related Quality of Life scores. Safety evaluation (incidence of adverse events, laboratory tests, electrocardiogram, vital signs) will be performed throughout the study. The study hypothesis is that topiramate will be effective in achieving and maintaining weight reduction in obese patients. During the initial 8 weeks, the doses of topiramate or placebo will be gradually increased to the target dose (either 96mg, 192mg, or 256mg daily by mouth) and the doses will be maintained for 2 years.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 1,293 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The percent change in body weight from the baseline (randomization) to Week 60 (after one year of maintenance therapy).
Changes from either baseline to Week 60 and/or Week 112, or enrollment to Week 60 and/or Week 112 in absolute body weight, Body Mass Index (BMI), body measurements, fasting lipid profile.
No study locations are listed for this record.
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.