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Trial record 13 of 14 for:    "Hansen's Disease" | "Anti-Infective Agents"

Effect of Weight and/or Obesity on Dapsone Drug Concentrations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01165840
Recruitment Status : Completed
First Posted : July 20, 2010
Results First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Ron Hall, Texas Tech University Health Sciences Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Obesity
Leprosy
Tuberculosis
Intervention Drug: Dapsone
Enrollment 37
Recruitment Details 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 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.
Arm/Group Title Dapsone
Hide Arm/Group Description

Dapsone 100 mg PO x 1 dose

Dapsone: 100 mg PO x 1 dose

Period Title: Overall Study
Started 36
Completed 36
Not Completed 0
Arm/Group Title Dapsone
Hide Arm/Group Description

Dapsone 100 mg PO x 1 dose

Dapsone: 100 mg PO x 1 dose

Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
1
   2.8%
Between 18 and 65 years
34
  94.4%
>=65 years
1
   2.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
38.2  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
18
  50.0%
Male
18
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Serum Clearance
Hide Description Serum clearance of dapsone
Time Frame 72 hours
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapsone
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Dapsone 100 mg PO x 1 dose

Dapsone: 100 mg PO x 1 dose

Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: L/h
2.55  (1.24)
Time Frame 72 hours
Adverse Event Reporting Description Participants were in the Clinical Research Unit under nursing supervision 0-24 hours after the dapsone dose. Research clinic visits occured at 48 and 72 hours after the dapsone dose under supervision of a research coordinator.
 
Arm/Group Title Dapsone
Hide Arm/Group Description

Dapsone 100 mg PO x 1 dose

Dapsone: 100 mg PO x 1 dose

All-Cause Mortality
Dapsone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dapsone
Affected / at Risk (%)
Total   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dapsone
Affected / at Risk (%)
Total   0/36 (0.00%) 
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
Responsible Party: Ron Hall, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01165840     History of Changes
Other Study ID Numbers: AMAIRB97
5UL1RR024982-02 ( U.S. NIH Grant/Contract )
First Submitted: July 16, 2010
First Posted: July 20, 2010
Results First Submitted: October 28, 2015
Results First Posted: July 21, 2016
Last Update Posted: July 21, 2016