Zonisamide for Weight Reduction in Obese Adults - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Zonisamide

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Change in body weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportions of patients with 5% and 10% weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Waist circumference [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Glycaemic indices [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Inflammatory markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Lipids [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Psychological measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	January 2006
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	May 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

Detailed Description:

This RCT compares two doses of zonisamide and placebo for one year. A total of 225 subjects are randomly assigned to one of the three treatment interventions 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

Criteria

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)

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275834

Locations

United States, North Carolina
Duke University Medical Centre
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Kishore M Gadde, MD

Duke University

More Information

No publications provided

Responsible Party:	Duke University Medical Center ( Kishore Gadde )
Study ID Numbers:	67352, 1-RO1-DK067352
Study First Received:	January 10, 2006
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00275834 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

obesity treatment
weight loss
antiobesity drugs
zonisamide

Additional relevant MeSH terms:

Obesity
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Zonisamide
Overweight
Protective Agents
Pharmacologic Actions
Body Weight

Signs and Symptoms
Therapeutic Uses
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 30, 2009