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| ID | Type | Description | Link |
|---|---|---|---|
| 5UL1RR024982-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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This study will find how weight affects the dosing of a drug called dapsone. Currently, the amount of dapsone a patient receives is the same regardless of the patient's weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapsone | Experimental | Dapsone 100 mg PO x 1 dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapsone | Drug | 100 mg PO x 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Clearance | Serum clearance of dapsone | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Hall, PharmD, MSCS | Texas Tech UHSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapsone | Dapsone 100 mg PO x 1 dose Dapsone: 100 mg PO x 1 dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapsone | Dapsone 100 mg PO x 1 dose Dapsone: 100 mg PO x 1 dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Clearance | Serum clearance of dapsone | Posted | Mean | Standard Deviation | L/h | 72 hours |
|
|
72 hours
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dapsone | Dapsone 100 mg PO x 1 dose Dapsone: 100 mg PO x 1 dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Hall | Texas Tech University HSC | 214-358-9009 | ronald.hall@ttuhsc.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007918 | Leprosy |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003622 | Dapsone |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 0 |
| 36 |
| 0 |
| 36 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009165 | Mycobacterium Infections, Nontuberculous |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |