Zonisamide for Weight Reduction in Obese Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00275834
First received: January 10, 2006
Last updated: July 9, 2014
Last verified: February 2013

January 10, 2006
July 9, 2014
January 2006
September 2011   (final data collection date for primary outcome measure)
Change in Body Weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.
Change in body weight
Complete list of historical versions of study NCT00275834 on ClinicalTrials.gov Archive Site
  • Proportions of Patients With 5% Weight Loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate.
  • Proportions of Patients With 10% Weight Loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.
  • Waist Circumference [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Analyses was based on intent-to-treat ANCOVA. Difference scores from baseline to endpoint (Month-12) for each measure were regressed on the three-level proxy denoting group while controlling for the baseline value of the same measure. Contrasts were subsequently estimated in models, which had a significant overall treatment effect.
  • 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 ]
  • Proportions of patients with 5% and 10% weight loss
  • Waist circumference
  • Glycaemic indices
  • Inflammatory markers
  • Lipids
  • Quality of life
  • Psychological measures
  • Blood pressure
Not Provided
Not Provided
 
Zonisamide for Weight Reduction in Obese Adults
Zonisamide for Weight Reduction in Obese Adults

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
Drug: Zonisamide
zonisamide 400 mg, 200 mg, or placebo
  • Experimental: A
    Zonisamide 400 mg
    Intervention: Drug: Zonisamide
  • Experimental: B
    Zonisamide 200 mg
    Intervention: Drug: Zonisamide
  • Placebo Comparator: C
    matching placebo
    Intervention: Drug: Zonisamide
Gadde KM, Kopping MF, Wagner HR, Yonish GM, Allison DB, Bray GA. Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial. Arch Intern Med. 2012 Nov 12;172(20):1557-64. doi: 10.1001/2013.jamainternmed.99.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
September 2011
September 2011   (final data collection date for primary outcome measure)

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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Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275834
Pro00005514, R01DK067352, 1-RO1-DK067352
Yes
Duke University
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Kishore M Gadde, MD Duke University
Duke University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP