CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 481 enrolled
Drug / intervention
Delamanid +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00685360
NCT00685360Phase 2Completed
CompareCT.gov

A Multi Center, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of OPC 67683 in Patients With Pulmonary Sputum Culture-Positive, Multidrug-resistant Tuberculosis

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted May 28, 2008·Updated Dec 1, 2021

In Brief

A Phase 2 clinical trial evaluating Delamanid, Optimized Background Regimen (OBR), and 1 other intervention for Tuberculosis, Pulmonary and 2 related conditions. Completed, enrolled 481 participants across 17 sites in 9 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
CountriesChina, Egypt, Estonia, Japan, Latvia, Peru, Philippines, South Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 28, 2008
Enrollment StartMay 8, 2008
Primary CompletionJun 11, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.1 years ago

Interventions

Delamaniddrug

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

Optimized Background Regimen (OBR)drug

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.

Placebodrug

Placebo tablets matching 50-mg tablets of delamanid