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

NCT00401271 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2007-03-07

No results posted yet for this study

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

DRUG

OPC-67683

DRUG

Rifafour e-275

Sponsors & Collaborators

  • Otsuka Frankfurt Research Institute GmbH

    lead INDUSTRY

Principal Investigators

  • Andreas H Diacon, Dr. · Tiervlei Trial Center

  • Roxana Rustomjee, Dr. · Medical Research Council

  • Rodney Dawson, Dr. · University of Cape Town Lung Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Completion
2007-03-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00401271 on ClinicalTrials.gov