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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: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00685360 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 481 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (262% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Sputum culture conversion was defined to occur at the time of the collection of a sputum specimen with mycobacterial culture negative for growth of Mycobacterium tuberculosis (MTB) followed by at least one additional sputum specimen with mycobacterial culture negative for growth at least 27 days after the first negative specimen and not followed by any sputum specimens positive for growth in the MGIT system at any point during the remainder of the 84-day trial after the first negative culture.
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 |
What the finished NCT00685360 record still lists
NCT00685360 is an interventional study that assigns participants to a tested intervention. The registered 481 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (262% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00685360 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00685360's enrollment target sits among peer trials
481 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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