NCT01131351 is a Phase 2 clinical trial of Delamanid in Tuberculosis, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

Who is sponsoring NCT01131351?

NCT01131351 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

What drugs are being tested in NCT01131351?

Interventions in NCT01131351: Delamanid, Optimized Background Regimen (OBR).

What condition does NCT01131351 study?

NCT01131351 studies Tuberculosis.

Is NCT01131351 still recruiting?

NCT01131351 is currently terminated. Last updated 11 November 2021.

Are results published for NCT01131351?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-11-11 · How we verify

NCT01131351

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 11 November 2021

What this trial tests

Phase 2 trial testing Delamanid in Tuberculosis in 10 participants. Terminated before completion.

Timeline

19 February 2010

Primary endpoint
12 May 2011

12 May 2011

Quick facts

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	19 February 2010
Primary completion	12 May 2011
Estimated completion	12 May 2011
Sites	3 locations across Lithuania, Latvia

Drugs / interventions tested

Delamanid — full drug profile →
Optimized Background Regimen (OBR) — full drug profile →

Conditions studied

Tuberculosis — all drugs for Tuberculosis →

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →

Who can join

Adults 18 to 64, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Potentially Clinically Significant Abnormalities in Vital Signs Primary · Up to approximately 40 weeks

Vital signs included body weight \[kilogram (kg)\], body temperature \[degree Celsius (°C)\], heart rate \[beats per minute (BPM)\], respiratory rate (breaths/minute), systolic and diastolic blood pressure \[millimeter of mercury (mmHg)\]. The criteria for clinically significant abnormal value were: body weight (kg): increase \>=5% or decrease \>=5%; body temperature (°C): \>=38.5°C and increase of \>=1.1°C; heart rate (BPM): \>=120 bpm and increase of \>=15 bpm, or \<=60 bpm and decrease of \>=15 bpm; systolic blood pressure (mmHg): \>=160 mmHg and increase of \>=20 mmHg, or \<=90 mmHg and de

Weight: Decrease of >=5% in Body Weight

Group	Value	95% CI
Delamanid 250 mg BID + OBR	60.0
Delamanid 300 mg BID + OBR	0.0

Weight: Increase of >=5% in Body Weight

Group	Value	95% CI
Delamanid 250 mg BID + OBR	20.0
Delamanid 300 mg BID + OBR	0.0

Heart Rate: <=60 bpm + Decrease of >=15 bpm

Group	Value	95% CI
Delamanid 250 mg BID + OBR	40.0
Delamanid 300 mg BID + OBR	20.0

Systolic Blood Pressure: <= 90 mmHg + Decrease of >=20 mmHg

Group	Value	95% CI
Delamanid 250 mg BID + OBR	40.0
Delamanid 300 mg BID + OBR	0.0

Respiration Rate: >30 Breaths Per Minute

Group	Value	95% CI
Delamanid 250 mg BID + OBR	20.0
Delamanid 300 mg BID + OBR	0.0

Percentage of Participants With Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) Results Primary · Up to approximately 40 weeks

The criteria for clinically significant abnormal ECG values were- ventricular rate outlier (\<50 bpm and decrease of \>=25%, \>100 bpm and increase of \>=25%), PR outlier \[increase of \>=25% when PR \>200 milliseconds (ms)\], QRS outlier (increase of \>=25% when QRS \>100 ms), QT (new onset (in treatment period but not at Baseline) \[\>500 ms\]), QT interval corrected by Bazett's formula (QTcB) (new onset \[\>450, \>480, \>500 ms\], increase of \>=30 ms and \<= 60 ms or increase of \>60 ms), QT interval corrected by Fridericia's formula (QTcF) (new onset \[\>450, \>480, \>500 ms\], increase o

Vent Rate Outliers: Notable Decreases

Group	Value	95% CI
Delamanid 250 mg BID + OBR	40.00
Delamanid 300 mg BID + OBR	0.00

Vent Rate Outliers: Notable Increases

Group	Value	95% CI
Delamanid 250 mg BID + OBR	40.00
Delamanid 300 mg BID + OBR	0.00

QTcB: New Onset (>500 msec)

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.00
Delamanid 300 mg BID + OBR	20.00

QTcB: New Onset (>480 msec)

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.00
Delamanid 300 mg BID + OBR	40.00

QTcB: New Onset (>450 msec)

Group	Value	95% CI
Delamanid 250 mg BID + OBR	40.00
Delamanid 300 mg BID + OBR	40.00

QTcB: Change >=30, <=60 msec

Group	Value	95% CI
Delamanid 250 mg BID + OBR	40.00
Delamanid 300 mg BID + OBR	80.00

QTcF: New Onset (>500 msec)

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.00
Delamanid 300 mg BID + OBR	20.00

QTcF: New Onset (>480 msec)

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.00
Delamanid 300 mg BID + OBR	20.00

Percentage of Participants With Potentially Clinically Significant Laboratory Values Primary · Up to approximately 40 weeks

Clinical laboratory tests included hematology, coagulation, chemistry, and urinalysis. The participants were categorized based on the clinically significant laboratory values as per protocol predefined criteria. The categories with at least one participant with clinically significant value outside the normal range for laboratory assessments are reported.

Lactic Dehydrogenase [units per liter (U/L)]

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.0
Delamanid 300 mg BID + OBR	20.0

Potassium [milliequivalents per liter (mEq/L)]

Group	Value	95% CI
Delamanid 250 mg BID + OBR	60.0
Delamanid 300 mg BID + OBR	20.0

Sodium (mEq/L)

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.0
Delamanid 300 mg BID + OBR	20.0

Triglycerides [milligrams per deciliter (mg/dL)]

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.0
Delamanid 300 mg BID + OBR	20.0

Uric acid (mg/dL)

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.0
Delamanid 300 mg BID + OBR	20.0

Lymphocytes [percentage (%)]

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.0
Delamanid 300 mg BID + OBR	20.0

Lymphocytes, Absolute [thousand cells per microliter (thous/µL)]

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.0
Delamanid 300 mg BID + OBR	20.0

Mean Corpuscular Volume [femtoliter (fL)]

Group	Value	95% CI
Delamanid 250 mg BID + OBR	20.0
Delamanid 300 mg BID + OBR	20.0

Percentage of Participants With Abnormal Audiometry Assessment Values Primary · Up to approximately 40 weeks

Group	Value	95% CI
Delamanid 250 mg BID + OBR	100.0
Delamanid 300 mg BID + OBR	80.0

Percentage of Participants With Abnormal Visual Acuity Assessment Values Primary · Up to approximately 40 weeks

Group	Value	95% CI
Delamanid 250 mg BID + OBR	40.0
Delamanid 300 mg BID + OBR	20.0

Percentage of Participants Taking Concomitant Anti-Tuberculosis (TB) Medication During the Trial Primary · Up to approximately 40 weeks

Total Participants Using One or More Medications

Group	Value	95% CI
Delamanid 250 mg BID + OBR	100.0
Delamanid 300 mg BID + OBR	100.0

Participants Taking Antibacterials for Systemic Use

Group	Value	95% CI
Delamanid 250 mg BID + OBR	80.0
Delamanid 300 mg BID + OBR	80.0

Participants Taking Antimycobacterials

Group	Value	95% CI
Delamanid 250 mg BID + OBR	100.0
Delamanid 300 mg BID + OBR	100.0

Percentage of Participants Taking Concomitant (Excluding Anti-TB) Medication During the Trial Primary · Up to approximately 40 weeks

Total Participants Using One or More Medications

Group	Value	95% CI
Delamanid 250 mg BID + OBR	100.0
Delamanid 300 mg BID + OBR	100.0

Participants Taking Agents Acting on the Renin-Angiotensin System

Group	Value	95% CI
Delamanid 250 mg BID + OBR	20.0
Delamanid 300 mg BID + OBR	20.0

Participants Taking Analgesics

Group	Value	95% CI
Delamanid 250 mg BID + OBR	40.0
Delamanid 300 mg BID + OBR	0.0

Participants Taking Antidiarrheals, Intestinal Antiinflammatory

Group	Value	95% CI
Delamanid 250 mg BID + OBR	20.0
Delamanid 300 mg BID + OBR	0.0

Participants Taking Antiepileptics

Group	Value	95% CI
Delamanid 250 mg BID + OBR	20.0
Delamanid 300 mg BID + OBR	0.0

Participants Taking Antigout Preparations

Group	Value	95% CI
Delamanid 250 mg BID + OBR	0.0
Delamanid 300 mg BID + OBR	20.0

Participants Taking Antihemorrhagics

Group	Value	95% CI
Delamanid 250 mg BID + OBR	20.0
Delamanid 300 mg BID + OBR	20.0

Participants Taking Antihypertensives

Group	Value	95% CI
Delamanid 250 mg BID + OBR	20.0
Delamanid 300 mg BID + OBR	0.0

Percentage of Participants With Adverse Events (AEs) Primary · Up to approximately 40 weeks

An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the investigator.

Group	Value	95% CI
Delamanid 250 mg BID + OBR	100.0
Delamanid 300 mg BID + OBR	100.0

Percentage of Participants With Immediately Reportable Events (IREs) Primary · Up to approximately 40 weeks

An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-participant hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above. The following were considered as IREs- serious adverse events (SAEs), pregnancies in trial participants or their partners, and all events involving ove

Group	Value	95% CI
Delamanid 250 mg BID + OBR	40.0
Delamanid 300 mg BID + OBR	40.0

Cmax: Maximal Peak Plasma Concentration for Delamanid Primary · At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196

Day 1

Group	Value	95% CI
Delamanid 250 mg BID + OBR	142	± 68.2
Delamanid 300 mg BID + OBR	192	± 93.5

Day 14

Group	Value	95% CI
Delamanid 250 mg BID + OBR	521	± 132
Delamanid 300 mg BID + OBR	514	± 99.3

Day 28

Group	Value	95% CI
Delamanid 250 mg BID + OBR	558	± 113
Delamanid 300 mg BID + OBR	573	± 117

Day 56

Group	Value	95% CI
Delamanid 250 mg BID + OBR	558	± 239
Delamanid 300 mg BID + OBR	503	± 126

Day 112

Group	Value	95% CI
Delamanid 250 mg BID + OBR	441	± 286
Delamanid 300 mg BID + OBR	427	± 114

Day 196

Group	Value	95% CI
Delamanid 250 mg BID + OBR	494	± 129
Delamanid 300 mg BID + OBR	499	± 241

Tmax: Time to Reach Maximal Peak Plasma Concentration for Delamanid Primary · At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196

Day 1

Group	Value	95% CI
Delamanid 250 mg BID + OBR	2.95	2.95 – 12.15
Delamanid 300 mg BID + OBR	3.20	3.00 – 11.88

Day 14

Group	Value	95% CI
Delamanid 250 mg BID + OBR	2.95	0.00 – 3.27
Delamanid 300 mg BID + OBR	3.02	2.53 – 3.05

Day 28

Group	Value	95% CI
Delamanid 250 mg BID + OBR	2.95	2.95 – 3.00
Delamanid 300 mg BID + OBR	3.03	3.00 – 8.92

Day 56

Group	Value	95% CI
Delamanid 250 mg BID + OBR	2.95	0.00 – 8.95
Delamanid 300 mg BID + OBR	3.00	3.00 – 8.97

Day 112

Group	Value	95% CI
Delamanid 250 mg BID + OBR	2.95	0.00 – 3.00
Delamanid 300 mg BID + OBR	3.03	3.00 – 3.05

Day 196

Group	Value	95% CI
Delamanid 250 mg BID + OBR	2.95	0.00 – 8.95
Delamanid 300 mg BID + OBR	3.00	3.00 – 3.00

AUC0-24h: Area Under the Plasma Concentration-Time Curve From 0 To 24 Hours for Delamanid Primary · At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196

AUC0-24h was calculated as 2×AUC0-12h.

Day 1

Group	Value	95% CI
Delamanid 250 mg BID + OBR	2020	± 708
Delamanid 300 mg BID + OBR	2650	± 1280

Day 14

Group	Value	95% CI
Delamanid 250 mg BID + OBR	9580	± 2790
Delamanid 300 mg BID + OBR	10400	± 1950

Day 28

Group	Value	95% CI
Delamanid 250 mg BID + OBR	9840	± 3090
Delamanid 300 mg BID + OBR	11200	± 2450

Day 56

Group	Value	95% CI
Delamanid 250 mg BID + OBR	10500	± 4490
Delamanid 300 mg BID + OBR	9720	± 2400

Day 112

Group	Value	95% CI
Delamanid 250 mg BID + OBR	8020	± 5470
Delamanid 300 mg BID + OBR	8470	± 3080

Day 196

Group	Value	95% CI
Delamanid 250 mg BID + OBR	9420	± 2340
Delamanid 300 mg BID + OBR	8640	± 2890

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug through end of study (Up to approximately 40 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Delamanid 250 mg BID + OBR

Serious: 2/5 (40%)

Deaths: 0/5

Delamanid 300 mg BID + OBR

Serious: 2/5 (40%)

Deaths: 1/5

Serious adverse events (10 terms)

Reaction	System	Delamanid 250 mg BID + OBR	Delamanid 300 mg BID + OBR
Tuberculosis	Infections and infestations	—	—
Lung lobectomy	Surgical and medical procedures	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Coronary artery disease	Cardiac disorders	—	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—	—
Electrocardiogram QT prolonged	Investigations	—	—
Alcohol abuse	Psychiatric disorders	—	—
Pneumonectomy	Surgical and medical procedures	—	—

Other adverse events (53 terms — click to expand)

Reaction	System	Delamanid 250 mg BID + OBR	Delamanid 300 mg BID + OBR
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Hepatomegaly	Hepatobiliary disorders	—	—
Tuberculosis	Infections and infestations	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Chest pain	General disorders	—	—
Weight decreased	Investigations	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—
Insomnia	Psychiatric disorders	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Atrioventricular block first degree	Cardiac disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Tinnitus	Ear and labyrinth disorders	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Toothache	Gastrointestinal disorders	—	—
Feeling cold	General disorders	—	—
Oedema peripheral	General disorders	—	—
Pyrexia	General disorders	—	—
Ulcer	General disorders	—	—
Hepatic pain	Hepatobiliary disorders	—	—
Bronchitis	Infections and infestations	—	—
Otitis media chronic	Infections and infestations	—	—
Viral infection	Infections and infestations	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Blood potassium increased	Investigations	—	—
Electrocardiogram ST-T change	Investigations	—	—
Reticulocyte count increased	Investigations	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Tuberculosis, Lung lobectomy, Anaemia, Acute myocardial infarction, Atrial fibrillation, Coronary artery disease, Post procedural haemorrhage, Electrocardiogram QT prolonged.

Data from ClinicalTrials.gov NCT01131351 adverse events section.

Sponsor's own description

The purpose of this study is: * To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background regimen of anti-TB medications (OBR). * To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Nitroimidazoles for the treatment of TB: past, present and future.
Mukherjee T, Boshoff H. · · 2011 · cited 77× · PMID 21879846 · DOI 10.4155/fmc.11.90
Population Pharmacokinetic Analysis of Delamanid in Patients with Pulmonary Multidrug-Resistant Tuberculosis.
Wang X, Mallikaarjun S, Gibiansky E. · · 2020 · cited 23× · PMID 33106258 · DOI 10.1128/aac.01202-20
Recently developed drugs for the treatment of drug-resistant tuberculosis: a research and development case study.
Perrin C, Athersuch K, Elder G, Martin M, et al · · 2022 · cited 15× · PMID 35440441 · DOI 10.1136/bmjgh-2021-007490

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01131351 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 11 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01131351.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01131351

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (10 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Delamanid

Other recruiting trials for Tuberculosis

Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials

Verify against primary sources