drugset / Trial / NCT02573350

A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683

NCT02573350

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

EvaluationDrugModalityDoseRoute
Subject Delamanid Small molecule 100 mg Oral
Subject Delamanid Small molecule 200 mg Oral