Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis
Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
Summary
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.