# Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis

> **NCT01131351** · PHASE2 · TERMINATED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 10 (actual)

## Conditions studied

- Tuberculosis

## Interventions

- **DRUG:** Delamanid
- **DRUG:** Optimized Background Regimen (OBR)

## Key facts

- **NCT ID:** NCT01131351
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2010-02-19
- **Primary completion:** 2011-05-12
- **Final completion:** 2011-05-12
- **Target enrollment:** 10 (ACTUAL)
- **Why stopped:** The study was terminated early due to lack of efficacy after 10 participants enrolled.
- **Last updated:** 2021-11-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01131351

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01131351, "Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT01131351. Licensed CC0.

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