NCT00401271

Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (planned)
• Sponsor: Otsuka Frankfurt Research Institute GmbH · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	OPC-67683
DRUG	Rifafour e-275

Timeline

• Start date: 2006-11-01
• Completion: 2007-03-01
• First posted: 2006-11-20
• Last updated: 2007-03-07

Locations

3 sites across 1 country: South Africa