A Phase 4 interventional study of Dapsone in Obesity, Leprosy and Tuberculosis, sponsored by Texas Tech University Health Sciences Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-21.
Sponsored by Texas Tech University Health Sciences Center · Phase 4, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 37 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Texas Tech University Health Sciences Center is the lead sponsor of 100 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dapsone 100 mg PO x 1 dose
Drug: Dapsone
100 mg PO x 1 dose
Serum Clearance
Serum clearance of dapsone
Time frame: 72 hours
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.
| Milestone | Dapsone |
|---|---|
| Started | 36 |
| Completed | 36 |
| Not completed | 0 |
Serum clearance of dapsone
| L/h | Dapsone |
|---|---|
| Serum Clearance | 2.55 ± 1.24 |
Collected over 72 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dapsone | — | 0/36 (0%) | 0/36 (0%) |
| Age, Categorical(Participants) | Dapsone |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 34 |
| >=65 years | 1 |
| Age, Continuous(years) | Dapsone |
|---|---|
| Mean | 38.2 ± 13.7 |
| Sex: Female, Male(Participants) | Dapsone |
|---|---|
| Female | 18 |
| Male | 18 |
| Region of Enrollment(participants) | Dapsone |
|---|---|
| United States | 36 |
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapsone
Texas Tech University Health Sciences Center →