Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis

PHASE3CompletedINTERVENTIONAL
Enrollment

511

Participants

Timeline

Start Date

September 2, 2011

Primary Completion Date

July 4, 2016

Study Completion Date

July 4, 2016

Conditions
Multidrug-resistant Tuberculosis
Interventions
DRUG

Delamanid + OBR

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.

DRUG

Placebo + OBR

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.

Trial Locations (17)

1101

Quezon City

1104

Quezon City

1230

Makati City

2571

Klerksdorp

4001

Durban

4114

Dasmariñas

7405

Cape Town

51014

Tartu

LV-2118

Riga

LT-76231

Šiauliai

LT-10214

Vilnius

MD2025

Chisinau

MD3737

Vorniceni

Lima 1

Alfonso Ugarte

Lima Cercado

Lima 7

Comas

Lima 10

El Agustino

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT01424670 - Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis | Biotech Hunter | Biotech Hunter