Effect of Weight and/or Obesity on Dapsone Drug Concentrations

This study has been completed.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Ron Hall, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01165840
First received: July 16, 2010
Last updated: June 9, 2016
Last verified: June 2016
Results First Received: October 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Obesity
Leprosy
Tuberculosis
Intervention: Drug: Dapsone

  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
Patients were recruited into three BMI groups to ensure a wide total body weight distribution, but only one pharmacokinetic model was analyzed with total body weight being one of the potential covariates that was assessed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty-seven patient provided consent, but only 36 started the study. One patient provided informed consent but was found to have G6PD and was not allowed to continue.

Reporting Groups
  Description
Dapsone

Dapsone 100 mg PO x 1 dose

Dapsone: 100 mg PO x 1 dose


Participant Flow:   Overall Study
    Dapsone  
STARTED     36  
COMPLETED     36  
NOT COMPLETED     0  



  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
Dapsone

Dapsone 100 mg PO x 1 dose

Dapsone: 100 mg PO x 1 dose


Baseline Measures
    Dapsone  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     34  
>=65 years     1  
Age  
[units: years]
Mean (Standard Deviation)
  38.2  (13.7)  
Gender  
[units: participants]
 
Female     18  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures

1.  Primary:   Serum Clearance   [ Time Frame: 72 hours ]


  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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ronald Hall
Organization: Texas Tech University HSC
phone: 214-358-9009
e-mail: ronald.hall@ttuhsc.edu



Responsible Party: Ron Hall, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01165840     History of Changes
Obsolete Identifiers: NCT01307930
Other Study ID Numbers: AMAIRB97
5UL1RR024982-02 ( US NIH Grant/Contract Award Number )
Study First Received: July 16, 2010
Results First Received: October 28, 2015
Last Updated: June 9, 2016
Health Authority: United States: Institutional Review Board