A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)

Phase 2 Completed 481 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2008-05-08
Primary completion: 2010-06-11
Completion: 2010-06-11

Outcome

Met primary endpoint

registry analysis (superiority test); Delamanid 100 mg BID + OBR vs Placebo + OBR; p =0.0083; Risk Ratio Mean 1.534 (95% CI 1.107 to 2.124); Cochran-Mantel-Haenszel NCT00685360 ↗

registry analysis (superiority test); Delamanid 200 mg BID + OBR vs Placebo + OBR; p =0.0393; Risk Ratio Mean 1.416 (95% CI 1.012 to 1.980); Cochran-Mantel-Haenszel NCT00685360 ↗

Publications

Gler MT, Skripconoka V, Sanchez-Garavito E, Xiao H, Cabrera-Rivero JL, Vargas-Vasquez DE, Gao M, Awad M, Park SK, Shim TS, Suh GY, Danilovits M, Ogata H, Kurve A, Chang J, Suzuki K, Tupasi T, Koh WJ, Seaworth B, Geiter LJ, Wells CD. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med. 2012 Jun 7;366(23):2151-60. doi: 10.1056/NEJMoa1112433.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delamanid	Small molecule	100 mg	Oral
Subject	Delamanid	Small molecule	200 mg	Oral