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: February 7, 2013
Last verified: February 2013
Results First Received: December 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obesity
Intervention: Drug: Zonisamide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at Duke University Medical Center between 2006 and 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.

Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling.

Zonisamide 200 mg Dosing of matching placebo was identical.
Zonisamide 400 mg No text entered.

Participant Flow:   Overall Study
    Placebo     Zonisamide 200 mg     Zonisamide 400 mg  
STARTED     74     76     75  
COMPLETED     71     73     74  
NOT COMPLETED     3     3     1  



  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.
No text entered.

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  
Number of Participants  
[units: participants]
  74     76     75     225  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     74     76     75     225  
>=65 years     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]
       
Female     44     45     45     134  
Male     30     31     30     91  
Region of Enrollment  
[units: participants]
       
United States     74     76     75     225  



  Outcome Measures
  Show All Outcome Measures

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   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Lipids   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Quality of Life   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Psychological Measures   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Blood Pressure   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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Time Frame 1-year
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Placebo No text entered.
Zonisamide 200 mg No text entered.
Zonisamide 400 mg No text entered.

Other Adverse Events
    Placebo     Zonisamide 200 mg     Zonisamide 400 mg  
Total, other (not including serious) adverse events        
# participants affected / at risk     30/74     37/76     39/75  
Gastrointestinal disorders        
Altered taste *      
# participants affected / at risk     0/74 (0.00%)     4/76 (5.26%)     4/75 (5.33%)  
Dry mouth *      
# participants affected / at risk     3/74 (4.05%)     5/76 (6.58%)     1/75 (1.33%)  
Nausea/vomiting *      
# participants affected / at risk     4/74 (5.41%)     4/76 (5.26%)     10/75 (13.33%)  
Musculoskeletal and connective tissue disorders        
Musculoskeletal problems *      
# participants affected / at risk     9/74 (12.16%)     11/76 (14.47%)     8/75 (10.67%)  
Nervous system disorders        
Impaired concentration        
# participants affected / at risk     1/74 (1.35%)     1/76 (1.32%)     4/75 (5.33%)  
Impaired memory *      
# participants affected / at risk     1/74 (1.35%)     5/76 (6.58%)     8/75 (10.67%)  
Headache *      
# participants affected / at risk     5/74 (6.76%)     8/76 (10.53%)     14/75 (18.67%)  
Fatigue *      
# participants affected / at risk     2/74 (2.70%)     4/76 (5.26%)     7/75 (9.33%)  
Somnolence *      
# participants affected / at risk     3/74 (4.05%)     9/76 (11.84%)     6/75 (8.00%)  
Psychiatric disorders        
Anxiety related *      
# participants affected / at risk     2/74 (2.70%)     5/76 (6.58%)     7/75 (9.33%)  
Depression related *      
# participants affected / at risk     3/74 (4.05%)     3/76 (3.95%)     5/75 (6.67%)  
* Events were collected by non-systematic assessment



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Kishore Gadde
Organization: Duke University Medical Center
phone: 919-668-0208
e-mail: kishore.gadde@duke.edu


Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00275834     History of Changes
Other Study ID Numbers: Pro00005514/67352, R01DK067352, 1-RO1-DK067352
Study First Received: January 10, 2006
Results First Received: December 10, 2012
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government