| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00275834 |
Purpose
The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.
| Condition | Intervention |
|
Obesity |
Drug: Zonisamide |
| MedlinePlus related topics: | Obesity Weight Control |
| ChemIDplus related topics: | Zonisamide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Zonisamide for Weight Reduction in Obese Adults |
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| A: Experimental |
Drug: Zonisamide
zonisamide 400 mg zonisamide 200 mg
|
| B: Experimental |
Drug: Zonisamide
zonisamide 400 mg zonisamide 200 mg
|
| C: Placebo Comparator |
Drug: Zonisamide
zonisamide 400 mg zonisamide 200 mg
|
This RCT will compared two doses of zonisamide and placebo for one year. A total of 300 subjects will be enrolled at Duke University Medical Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes include changes in waist circumference, glycaemic and inflammatory markers, lipids, food craving, hunger and satiety, quality of life, blood pressure and heart rate.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Age 18-65 years; BMI 30-50
Exclusion Criteria:
Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks)
-
Contacts and Locations| Contact: Gretchen M Yonish, RD | Yonis002@mc.duke.edu |
| United States, North Carolina | |||||
| Duke University Medical Centre | Recruiting | ||||
| Durham, North Carolina, United States, 27710 | |||||
| Principal Investigator: | Kishore M Gadde, MD | Duke University |
More Information
| Responsible Party: | Duke University Medical Center ( Kishore Gadde ) |
| Study ID Numbers: | 67352, 1-RO1-DK067352 |
| First Received: | January 10, 2006 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00275834 |
| Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
|
|
|
|
|
|
