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NCT00685360 · ClinicalTrials.gov registry record · Phase 2
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 481
- Enrollment target
NCT00685360 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 481 participants.
The verdict
NCT00685360, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 481 participants
- Enrollment target
Study Summary
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days. In addition to an optimized background regimen (OBR), participants will be randomized to receive: * 100 mg OPC-67683 twice daily (BID) * 200 mg OPC-67683 BID * Placebo BID After 56 days participants will complete their optimized background regimen (OBR).
Interventions
- DRUG Placebo
- DRUG Optimized Background Regimen (OBR)
- DRUG Delamanid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2008-05-08 |
| Est. Completion | 2010-06-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00685360
The ClinicalTrials.gov registry entry for NCT00685360 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 481 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00685360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00685360 about?
NCT00685360 is a clinical study titled "A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)". This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days. In addition to an optimized background regimen (OBR), participants will be randomized to receive: * 100 mg OPC-67683 twice daily (BID) * 200 mg OPC-67...
What is the current status of trial NCT00685360?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 481 participants. The study started on 2008-05-08. Estimated completion is 2010-06-11.
What interventions are being tested in trial NCT00685360?
The interventions under investigation include: Placebo (DRUG), Optimized Background Regimen (OBR) (DRUG), Delamanid (DRUG).
Who is sponsoring clinical trial NCT00685360?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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