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Tracking Information | |||||||||||||
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First Received Date † | November 17, 2006 | ||||||||||||
Last Updated Date | March 6, 2007 | ||||||||||||
Start Date † | November 2006 | ||||||||||||
Current Primary Outcome Measures † |
TB bacterial load in sputum measured as colony forming units | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00401271 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis | ||||||||||||
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 | ||||||||||||
Brief 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. |
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Detailed Description | |||||||||||||
Study Phase | Phase II | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment | ||||||||||||
Condition † | Pulmonary Tuberculosis | ||||||||||||
Intervention † |
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Study Arms / Comparison Groups | |||||||||||||
Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Completed | ||||||||||||
Enrollment † | 54 | ||||||||||||
Completion Date | March 2007 | ||||||||||||
Primary Completion Date | |||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 18 Years to 64 Years | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | South Africa | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00401271 | ||||||||||||
Responsible Party | |||||||||||||
Secondary IDs †† | |||||||||||||
Study Sponsor † | Otsuka Frankfurt Research Institute GmbH | ||||||||||||
Collaborators †† | |||||||||||||
Investigators † |
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Information Provided By | Otsuka Frankfurt Research Institute GmbH | ||||||||||||
Verification Date | March 2007 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |