CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 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/NCT01859923
NCT01859923Phase 2Completed
CompareCT.gov

Phase 2, Open-label, Multiple-dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Delamanid (OPC-67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs Over a 6-Month Treatment Period

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted May 22, 2013·Updated Nov 23, 2020

In Brief

A Phase 2 clinical trial evaluating Delamanid, Delamanid Pediatric Formulation (DPF), and 1 other intervention for Multidrug Resistant Tuberculosis. Completed, enrolled 37 participants across 3 sites in 2 countries.

Detailed Summary

The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in pediatric participants who completed Study 242-12-232 (NCT01856634).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultidrug Resistant Tuberculosis
CountriesPhilippines, South Africa
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 22, 2013
Enrollment StartJul 20, 2013
Primary CompletionJan 13, 2020
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 13.1 years ago

Interventions

Delamaniddrug

Participants received adult formulation delamanid as per regimen specified in the arm description. Morning dose of the delamanid BID regimen was given within 30 minutes after the start of a standard breakfast meal. The evening dose of the BID dose regimen was given 10 hours post morning dose and within 30 minutes after the start of a standard dinner meal.

Delamanid Pediatric Formulation (DPF)drug

Participants received delamanid as an extemporaneous suspension using the delamanid pediatric dispersible tablet formulation. Morning dose of the delamanid BID/once daily (QD) regimen was given within 30 minutes after the start of a standard breakfast meal. The evening dose of the BID dose regimen was given 10 hours post morning dose and within 30 minutes after the start of a standard meal.

Optimized Background Regimen (OBR)drug

Selection and administration of the treatment medications (i.e. OBRs) was based on Search Results Web result with site links World Health Organization (WHO's) Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines. Study Investigator could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results.