NCT02573350

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

A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683 as 100 mg BID With Optional Titration to 200 mg BID for up to Six Months Exposure in Patients With Pulmonary Multi-drug Resistant Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis, Multidrug-Resistant

Interventions

Type	Name	Description
DRUG	Delamanid	Delamanid was administered orally twice daily as 50-mg tablets under fed conditions in the morning and evening.
DRUG	OBR	Selection and administration of the treatment medications (i.e. OBRs) was based on World Health Organization (WHO's) Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines. Study investigators could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results.

Timeline

• Start date: 2009-03-26
• Primary completion: 2011-10-27
• Completion: 2011-10-27
• First posted: 2015-10-09
• Last updated: 2021-11-01
• Results posted: 2021-11-01

Locations

8 sites across 6 countries: China, Estonia, Latvia, Peru, Philippines, South Korea

Regulatory

• FDA-regulated drug study