Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis
The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg, 200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days, in patients with uncomplicated, smear-positive pulmonary TB.
The four OPC-67683 treatment groups will comprise 12 patients each and the one standard therapy (Rifafour e-275) group six patients.
Trial 242-06-101 is an exploratory and not a confirmatory trial and as such no hypothesis will be tested statistically.
The control group, six patients treated with Rifafour, will serve as an control to confirm the microbiological assessments during the trial.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Four Oral Doses of OPC-67683 in Patients With Uncomplicated, Smear-Positive, Pulmonary Tuberculosis|
|Tiervlei Trial Center, Karl Bremer Hospital|
|Bellville, W Cape, South Africa, 7531|
|University of Cape Town Lung Institute|
|Mowbray, W Cape, South Africa, 7700|
|Medical Research Council|
|Durban, South Africa, 4000|
|Principal Investigator:||Andreas H Diacon, Dr.||Tiervlei Trial Center|
|Principal Investigator:||Roxana Rustomjee, Dr.||Medical Research Council|
|Principal Investigator:||Rodney Dawson, Dr.||University of Cape Town Lung Institute|