Trial · NCT02573350
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
NCT02573350, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2021-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683. Trials, record NCT02573350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02573350
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
- NCT number
- NCT02573350
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 213 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Tuberculosis, Multidrug-Resistant
- Interventions
- Delamanid, OBR
- First posted
- 2015-10-09
- Last updated
- 2021-11-01
- Other registries' IDs
- eudract:2008-005107-26
- Results first posted
- 2021-11-01
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Abnormality in Vital Signs | From first dose of study drug up to Week 26 | Vital signs included weight (kg), body temperature (degree Celsius), heart rate \[beats/minute (bpm)\], systolic and diastolic blood pressure \[millimetre of mercury (mm Hg)\]. The criteria for clinically significant abnormal value for: weight was decrease or increase of \>=5% in body weight, heart rate was \<=60 bpm and decrease of \>=15 bpm; \>=120 bpm and Increase of \>=15 bpm, systolic blood pressure (SBP) \<=90 mm Hg and decrease of \>=20 mm Hg; diastolic blood pressure (DBP) \<=50 mm Hg and decrease of \>=15 mm Hg, all vital signs relative to Baseline. Baseline is Study 204 completion visit (Day 84) for participants who complete the baseline visit within 7 days of completing Study 204. Only categories with data for potentially clinically significant abnormal vital sign parameter values are reported. |
| Primary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values | From first dose of study drug up to Week 26 | 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 of \>=30 ms and \<= 60 ms or increase of \>60 ms), new abnormal U waves, new ST segment changes, new T wave changes, new abnormal rhythm, new conduction abnormality were reported as categories. Only categories with data are reported. |
| Primary | Number of Participants With Clinical Significant Abnormality in Laboratory Test | From first dose of study drug up to Week 26 | Laboratory assessments included parameters for serum chemistry (alkaline phosphatase, alanine aminotransferase, alanine transaminase, total bilirubin, cholesterol, gamma-glutamyl transferase, glucose, lactic dehydrogenase, potassium, sodium, triglycerides, uric acid), hematology (white blood cell count eosinophils, absolute, hematocrit, hemoglobin, lymphocytes, absolute, mean corpuscular volume, neutrophil, bands, neutrophils, neutrophils, absolute, platelet count, red blood cell (RBC) count, reticulocyte count) and urinalysis (blood, epithelial cast, granular cast, hyaline cast, RBCs per high power field (RBC/HPF)). The participants were categorized based on the clinically significant laboratory values as per predefined criteria. The categories with at least one participant with clinically significant value outside the normal range for laboratory assessments are reported. |
| Primary | Number of Participants With Abnormality in Audiometry at Baseline | Baseline | Audiometry assessments were done at Baseline. |
| Primary | Number of Participants With Abnormality in Visual Acuity | From first dose of study drug up to Week 26 | |
| Primary | Number of Participants With Abnormality in Neurological and Psychiatric Assessment Reported as Treatment-emergent Adverse Event (TEAE) | From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) | Participants with abnormal neurological and psychiatric assessments were reported. An adverse event (AE) is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A TEAE is any new AE or worsening of an existing condition after initiation of study drug. |
| Primary | Number of Participants With Clinical Significant Abnormality in Thyroid Function Test Reported as TEAE | From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) | Participants with abnormal thyroid free T4 nanograms per deciliter (ng/dL) and thyroid-stimulating hormone (\>=3 OR \<=0.3 micro-international units per litre (uIU/mL). An AE is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A TEAE is any new AE or worsening of an existing condition after initiation of study drug. |
| Primary | Number of Participants With Any Concomitant Medication Usage | From first dose of study drug up to Week 26 | Concomitant medications are defined as medications that started on or after the first day of study treatment or were started prior to study treatment but were ongoing on the first day of study treatment. |
| Primary | Percentage of Participants With At Least One TEAEs and Serious Adverse Events (SAEs) | From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) | An adverse event (AE) is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A TEAE is any new AE or worsening of an existing condition after initiation of study drug. An SAE is an AE that resulted in death, inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. |
| Primary | Number of Participants With Clinical Significant Abnormality in Coagulation (PT and aPTT) Reported as TEAE | From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) | Participants with clinically significant abnormal coagulation (prothrombin time (PT) \>17.5 seconds and activated partial thromboplastin time (aPTT) \>45 seconds) were reported. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinically Significant Abnormality in Vital Signs | From first dose of study drug up to Week 26 | Safety Population included all participants treated with at least one dose of Delamanid in this study. Number analyzed is the number of participants with data available for analyses at the given time point. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values | From first dose of study drug up to Week 26 | Safety Population included all participants treated with at least one dose of Delamanid in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Significant Abnormality in Laboratory Test | From first dose of study drug up to Week 26 | Safety Population included all participants treated with at least one dose of Delamanid in this study. Number analyzed is the number of participants with at least one post-baseline result for the given test. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormality in Audiometry at Baseline | Baseline | Safety Population included all participants treated with at least one dose of Delamanid in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormality in Visual Acuity | From first dose of study drug up to Week 26 | Safety Population included all participants treated with at least one dose of Delamanid in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormality in Neurological and Psychiatric Assessment Reported as Treatment-emergent Adverse Event (TEAE) | From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) | Safety Population included all participants treated with at least one dose of Delamanid in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Significant Abnormality in Thyroid Function Test Reported as TEAE | From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) | Safety Population included all participants treated with at least one dose of Delamanid in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Concomitant Medication Usage | From first dose of study drug up to Week 26 | Safety Population included all participants treated with at least one dose of Delamanid in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With At Least One TEAEs and Serious Adverse Events (SAEs) | From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) | Safety Population included all participants treated with at least one dose of Delamanid in this study. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Clinical Significant Abnormality in Coagulation (PT and aPTT) Reported as TEAE | From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) | Safety Population included all participants treated with at least one dose of Delamanid in this study. Number analyzed is the number of participants with at least one post-baseline result for the given test. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group158
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 100 mg BID + OBR | Weight Decrease of >=5% | 23 | Participants | |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 200 mg BID + OBR | Weight Decrease of >=5% | 11 | Participants | |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 100 mg BID + OBR | Weight Increase of >=5% | 34 | Participants | |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 200 mg BID + OBR | Weight Increase of >=5% | 25 | Participants | |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 100 mg BID + OBR | Heart Rate: <=60 bpm and Decrease of >=15 bpm | 10 | Participants | |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 200 mg BID + OBR | Heart Rate: <=60 bpm and Decrease of >=15 bpm | 11 | Participants | |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 100 mg BID + OBR | Heart Rate: >=120 bpm and Increase of >=15 bpm | 1 | Participants | |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 200 mg BID + OBR | Heart Rate: >=120 bpm and Increase of >=15 bpm | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 100 mg BID + OBR | SBP: <=90 mm Hg and Decrease of >=20 mm Hg | 16 | Participants | |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Delamanid 200 mg BID + OBR | SBP: <=90 mm Hg and Decrease of >=20 mm Hg | 2 | Participants |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Delamanid 100 mg BID + OBR | 137 | |
| Overall Study | STARTED | Delamanid 200 mg BID + OBR | 76 | |
| Overall Study | Efficacy Analysis Population | Delamanid 100 mg BID + OBR | 132 | |
| Overall Study | Efficacy Analysis Population | Delamanid 200 mg BID + OBR | 73 | |
| Overall Study | Safety Population | Delamanid 100 mg BID + OBR | 137 | |
| Overall Study | Safety Population | Delamanid 200 mg BID + OBR | 76 | |
| Overall Study | COMPLETED | Delamanid 100 mg BID + OBR | 121 | |
| Overall Study | COMPLETED | Delamanid 200 mg BID + OBR | 67 | |
| Overall Study | NOT COMPLETED | Delamanid 100 mg BID + OBR | 16 | |
| Overall Study | NOT COMPLETED | Delamanid 200 mg BID + OBR | 9 |
Source ClinicalTrials.gov
Adverse events130
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Delamanid 100 mg BID + OBR | 18 | 137 | |
| other | Palpitations | Cardiac disorders | Delamanid 200 mg BID + OBR | 0 | 76 | |
| other | Tinnitus | Ear and labyrinth disorders | Delamanid 100 mg BID + OBR | 16 | 137 | |
| other | Tinnitus | Ear and labyrinth disorders | Delamanid 200 mg BID + OBR | 5 | 76 | |
| other | Abdominal pain | Gastrointestinal disorders | Delamanid 100 mg BID + OBR | 8 | 137 | |
| other | Abdominal pain | Gastrointestinal disorders | Delamanid 200 mg BID + OBR | 1 | 76 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Delamanid 100 mg BID + OBR | 7 | 137 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Delamanid 200 mg BID + OBR | 1 | 76 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Delamanid 100 mg BID + OBR | 19 | 137 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Delamanid 200 mg BID + OBR | 6 | 76 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Delamanid 100 mg BID + OBR | 1 | 137 |
| Total, all-cause mortality | Delamanid 200 mg BID + OBR | 0 | 76 |
| Total, other adverse events | Delamanid 100 mg BID + OBR | 126 | 137 |
| Total, other adverse events | Delamanid 200 mg BID + OBR | 73 | 76 |
| Total, serious adverse events | Delamanid 100 mg BID + OBR | 19 | 137 |
| Total, serious adverse events | Delamanid 200 mg BID + OBR | 6 | 76 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Delamanid 100 mg BID + OBR vs Delamanid 200 mg BID + OBR: Number of Participants With Abnormality in Audiometry at Baseline | Trial comparisons |
| Delamanid 100mg BID + OBR vs Delamanid 200mg BID + OBR: Number of Participants With Clinical Significant Abnormality in Thyroid Function Test Reported as TEAE | Trial comparisons |
| Delamanid 100 mg BID + OBR vs Delamanid 200 mg BID + OBR: Number of Participants With Any Concomitant Medication Usage | Trial comparisons |
| Delamanid 100mg BID + OBR vs Delamanid 200mg BID + OBR: Number of Participants With Clinical Significant Abnormality in Cortisol | Trial comparisons |
| Delamanid 100 mg BID + OBR vs Delamanid 200 mg BID + OBR: deaths from any cause | Trial comparisons |
| Delamanid 100 mg BID + OBR vs Delamanid 200 mg BID + OBR: Number of Participants With Abnormality in Visual Acuity | Trial comparisons |
| Delamanid 100 mg BID + OBR vs Delamanid 200 mg BID + OBR: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02573350
GET https://conductscience.org/api/trials/v1/NCT02573350/registered?page=2