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Sponsored by: |
Otsuka Frankfurt Research Institute GmbH |
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Information provided by: | Otsuka Frankfurt Research Institute GmbH |
ClinicalTrials.gov Identifier: | NCT00401271 |
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.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Tuberculosis |
Drug: OPC-67683 Drug: Rifafour e-275 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
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 |
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Treatment received with quinolones and prednisolone within 3 months prior to Screening.
South Africa | |
Medical Research Council | |
Durban, South Africa, 4000 | |
South Africa, W Cape | |
Tiervlei Trial Center, Karl Bremer Hospital | |
Bellville, W Cape, South Africa, 7531 | |
University of Cape Town Lung Institute | |
Mowbray, W Cape, South Africa, 7700 |
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 |
Study ID Numbers: | 242-06-101 |
Study First Received: | November 17, 2006 |
Last Updated: | March 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00401271 History of Changes |
Health Authority: | South Africa: Medicines Control Council |
Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis |
Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases |
Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis Actinomycetales Infections |