CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
Delamanid + OBR +1 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/NCT01424670
NCT01424670Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid (OPC-67683) Administered Orally as 200 mg Total Daily Dose for Six Months in Patients With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 29, 2011·Updated May 15, 2019

In Brief

A Phase 3 clinical trial evaluating Delamanid + OBR and Placebo + OBR for Multidrug-resistant Tuberculosis. Completed, enrolled 511 participants across 17 sites in 7 countries.

Detailed Summary

The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultidrug-resistant Tuberculosis
CountriesEstonia, Latvia, Lithuania, Moldova, Peru, Philippines, South Africa
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2011
Enrollment StartSep 2, 2011
Primary CompletionJul 4, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.8 years ago

Interventions

Delamanid + OBRdrug

The assigned doses of delamanid were administered with an OBR. The selection and administration of the OBR were based on WHO's guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country.

Placebo + OBRdrug

Matching placebo was administered with an OBR. The selection and administration of the OBR were based on WHO's guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country.