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Trial Outcomes & Findings for Effect of Weight and/or Obesity on Dapsone Drug Concentrations (NCT NCT01165840)

NCT ID: NCT01165840

Last Updated: 2016-07-21

Results Overview

Serum clearance of dapsone

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

72 hours

Results posted on

2016-07-21

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
Dapsone
Dapsone 100 mg PO x 1 dose Dapsone: 100 mg PO x 1 dose
Overall Study
STARTED
36
Overall Study
COMPLETED
36
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Weight and/or Obesity on Dapsone Drug Concentrations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dapsone
n=36 Participants
Dapsone 100 mg PO x 1 dose Dapsone: 100 mg PO x 1 dose
Age, Categorical
<=18 years
1 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
34 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Age, Continuous
38.2 years
STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
Sex: Female, Male
Male
18 Participants
n=5 Participants
Region of Enrollment
United States
36 participants
n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Serum clearance of dapsone

Outcome measures

Outcome measures
Measure
Dapsone
n=36 Participants
Dapsone 100 mg PO x 1 dose Dapsone: 100 mg PO x 1 dose
Serum Clearance
2.55 L/h
Standard Deviation 1.24

Adverse Events

Dapsone

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronald Hall

Texas Tech University HSC

Phone: 214-358-9009

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place