ObesityPhase 4NCT01165840
Effect of Weight and/or Obesity on Dapsone Drug Concentrations
A Phase 4 study testing Dapsone in people with Obesity and Leprosy, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Leprosy, Tuberculosis
- What is being tested?
- Dapsone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects, age >18 years, of all racial and ethnic origins.
- Non-English speaking Spanish speakers will be included in the study.
- We are recruiting 12 normal or underweight (BMI <25 kg/m2), 12 overweight or obese (BMI 25-40 kg/m2), and 12 extremely obese (BMI > 40 kg/m2) for this study. This index is calculated using the volunteer's height and weight (Formula: weight (lb) / [height (in)]2 x 703). Half of each group will be male; the other half will be female.
Who cannot join
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of dapsone on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of dapsone, so that the pregnancy and post-partum state would be a confounding variable.
- Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
- History of allergies to dapsone, sulfones, or sulfonamides.
- Dapsone, sulfones, or sulfonamides are contraindicated for any reason.
- Volunteers unwilling to comply with study procedures.
- Current suspected or documented infection of any kind.
Show all 11Show fewer
- Volunteers with colon resection, gastric bypass, lap band, or any other conditions inhibiting gastric absorption of drug.
- Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by PI.
- Donation of 450 milliliters (ml) (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
- Current use of zidovudine, amprenavir, rifabutin, rifapentine, or saquinavir.
- Creatinine clearance < 70 ml/minute (min) as estimated by the Cockcroft-gault equation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern
Dallas, Texas, 75390
About this study
Official title: Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers
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.
- Conditions
- Obesity, Leprosy, Tuberculosis
- Being tested
- Dapsone
- Keywords
- Obesity, Pharmacokinetics, Dapsone, Leprosy, Tuberculosis
- Medical subject headings
- Obesity, Leprosy, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapsoneDrug
100 mg PO x 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Dapsone | Experimental | Dapsone 100 mg PO x 1 dose Receives: Drug: Dapsone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Clearance
Serum clearance of dapsone
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Ron Hall, Texas Tech University Health Sciences Center
- Investigators
- Ronald Hall, PharmD, MSCS, Principal investigator, Texas Tech UHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165840
- Sponsor's protocol ID
- AMAIRB97
- Other IDs
- 5UL1RR024982-02
- Status last verified
- Jun 2016
- First submitted
- 16 Jul 2010
- Last updated
- 21 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers
- ClinicalTrials.gov ID
- NCT01165840
- Acronym / sponsor ID
- AMAIRB97
- Conditions
- Obesity, Leprosy, Tuberculosis
- Keywords
- Obesity, Pharmacokinetics, Dapsone, Leprosy, Tuberculosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Jul 2010 (estimated)
- Results
- Posted 21 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dapsone | Experimental | Drug: DapsoneDapsone 100 mg PO x 1 dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects, age >18 years, of all racial and ethnic origins.
- Non-English speaking Spanish speakers will be included in the study.
- We are recruiting 12 normal or underweight (BMI <25 kg/m2), 12 overweight or obese (BMI 25-40 kg/m2), and 12 extremely obese (BMI > 40 kg/m2) for this study. This index is calculated using the volunteer's height and weight (Formula: weight (lb) / [height (in)]2 x 703). Half of each group will be male; the other half will be female.
Key exclusion criteria (11 listed)
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of dapsone on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of dapsone, so that the pregnancy and post-partum state would be a confounding variable.
- Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
- History of allergies to dapsone, sulfones, or sulfonamides.
- Dapsone, sulfones, or sulfonamides are contraindicated for any reason.
- Volunteers unwilling to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapsone100 mg PO x 1 dose | Drug | Dapsone |
Primary outcome
Serum Clearance
Time frame: 72 hours
Serum clearance of dapsone
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Hall, PharmD, MSCS principal investigator
Texas Tech UHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapsone in people with Obesity and Leprosy, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Clearance (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.