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placebo + OBR
- Development stage
- Unknown
- Lead developer
- Otsuka Holdings
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
placebo + OBR refers to the control arm used in clinical trials for multidrug-resistant tuberculosis (MDR-TB), specifically in studies conducted by Otsuka Pharmaceutical Development & Commercialization, Inc. (such as Trial 213/NCT01424670). In this regimen, patients receive a matching placebo instead of the investigational agent (delamanid), alongside an Optimized Background Regimen (OBR). The OBR is a combination of existing anti-tuberculosis medications selected based on World Health Organization (WHO) guidelines and national program standards, tailored to the resistance profile of the patient's Mycobacterium tuberculosis strain. This regimen serves as the standard of care comparator to evaluate the safety and efficacy of adding new therapeutic agents to existing MDR-TB treatments.
- Other names
- placebo plus OBRplacebo plus optimized background regimen
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