drugset / Trial / NCT02573350
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
RandomizedParallel-groupOpen-labelTreatment
Summary
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible. The trial was performed globally at 14 sites qualified to treat MDR-TB. All 434 participants who completed Trial 242-07-204 were eligible for this trial if there was still potential clinical benefit to them and all inclusion criteria and no exclusion criteria were met.
Timeline
- Start
- 2009-03-26
- Primary completion
- 2011-10-27
- Completion
- 2011-10-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Delamanid | Small molecule | 100 mg | Oral |
| Subject | Delamanid | Small molecule | 200 mg | Oral |