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Zonisamide for Weight Reduction in Obese Adults

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00275834
First received: January 10, 2006
Last updated: November 15, 2016
Last verified: November 2016
Results First Received: December 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obesity
Intervention: Drug: Zonisamide

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo No text entered.
Zonisamide 200 mg No text entered.
Zonisamide 400 mg No text entered.
Total Total of all reporting groups

Baseline Measures
   Placebo   Zonisamide 200 mg   Zonisamide 400 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 74   76   75   225 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      74 100.0%      76 100.0%      75 100.0%      225 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.5  (10.3)   44.2  (10.1)   42.3  (10.0)   43.4  (10.1) 
Gender 
[Units: Participants]
Count of Participants
       
Female      44  59.5%      45  59.2%      45  60.0%      134  59.6% 
Male      30  40.5%      31  40.8%      30  40.0%      91  40.4% 
Region of Enrollment 
[Units: Participants]
       
United States   74   76   75   225 


  Outcome Measures
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1.  Primary:   Change in Body Weight   [ Time Frame: 1 year ]

2.  Secondary:   Proportions of Patients With 5% Weight Loss   [ Time Frame: 1 year ]

3.  Secondary:   Proportions of Patients With 10% Weight Loss   [ Time Frame: 1 year ]

4.  Secondary:   Waist Circumference   [ Time Frame: 1 year ]

5.  Secondary:   Inflammatory Markers (CRP)   [ Time Frame: 1 year ]

6.  Secondary:   Change in Lipids   [ Time Frame: baseline, 1 year ]

7.  Secondary:   Quality of Life as Measured by HADS_D   [ Time Frame: 1 year ]

8.  Secondary:   Change in Blood Pressure   [ Time Frame: Baseline, 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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