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

NCT00685360 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 481

Last updated 2021-12-01

Study results available
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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).

Conditions

  • Tuberculosis, Pulmonary
  • Tuberculosis, Multidrug Resistant
  • Extensively Drug-Resistant Tuberculosis

Interventions

DRUG

Delamanid

Delamanid was administered orally twice daily as 50-mg tablets under fed conditions in the morning and evening.

DRUG

Optimized Background Regimen (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 in each country. Study Investigator could change OBR for a participant based on participant's tolerability and drug susceptibility testing (DST) results.

DRUG

Placebo

Placebo tablets matching 50-mg tablets of delamanid

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-08
Primary Completion
2010-06-11
Completion
2010-06-11
FDA Drug
Yes

Countries

  • United States
  • China
  • Egypt
  • Estonia
  • Japan
  • Latvia
  • Peru
  • Philippines
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00685360 on ClinicalTrials.gov