Trial · NCT00685360
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
NCT00685360, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2021-12-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB). Trials, record NCT00685360. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00685360
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
- NCT number
- NCT00685360
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 481 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Interventions
- Delamanid, Optimized Background Regimen (OBR), Placebo
- First posted
- 2008-05-28
- Last updated
- 2021-12-01
- Other registries' IDs
- eudract:2007-005229-31
- Results first posted
- 2021-12-01
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Sputum Culture Conversion (SCC) Using the Mycobacteria Growth Indicator Tube (MGIT) System | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 84) | Sputum culture conversion was defined to occur at the time of the collection of a sputum specimen with mycobacterial culture negative for growth of Mycobacterium tuberculosis (MTB) followed by at least one additional sputum specimen with mycobacterial culture negative for growth at least 27 days after the first negative specimen and not followed by any sputum specimens positive for growth in the MGIT system at any point during the remainder of the 84-day trial after the first negative culture. |
| Primary | Tmax 1 and 2: Time to Maximal Peak Concentration (Tmax) for Delamanid Following First and Second Daily Dose | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Time to maximum (peak) plasma concentration following the first daily dose (Cmax1) was reported as tmax1 and time to maximum (peak) plasma concentration following the second daily dose (Cmax2) was reported as tmax2. Data for Tmax up to Day 56 was collected on Days 1, 14, 28 and 56. |
| Primary | Cmax 1 and 2: Maximal Peak Concentration (Cmax) for Delamanid Following First and Second Daily Dose | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Maximum (peak) plasma concentration following the first daily dose was reported as Cmax1 and maximum (peak) plasma concentration following the second daily dose was reported as Cmax2. Data for Cmax up to Day 56 was collected on Days 1, 14, 28 and 56. |
| Primary | Area Under the Plasma Concentration Curve From 0 to 24 Hours (AUC0-24h) for Delamanid | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Data for AUC0-24h up to Day 56 was collected on Days 1, 14, 28 and 56. |
| Primary | Accumulation Ratio for Cmax (Rac[Cmax]) for Delamanid | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Data for Rac (Cmax) up to Day 56 was collected on Days 14, 28 and 56. Rac (Cmax) on Days 14, 28 or 56 compared to Cmax on Day 1 was computed. |
| Primary | Accumulation Ratio for AUC From Time 0 to 24 Hours (Rac[AUC0-24h]) for Delamanid | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Data for Rac (AUC) up to Day 56 was collected on Days 14, 28 and 56. Rac (AUC) on Days 14, 28 or 56 compared to AUC0-24h on Day 1 was computed. |
| Primary | Time to Maximal Peak Concentration (Tmax) for Delamanid Metabolite (DM)-6704, DM-6705, DM-6706, DM-6717, DM-6718, DM-6720, DM-6721, and DM-6722 | 0 hours (morning pre-dose), 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Data for Tmax up to Day 56 was collected on Days 1, 14, 28 and 56. |
| Primary | Maximal Peak Concentration (Cmax) for DM-6704, DM-6705, DM-6706, DM-6717, DM-6718, DM-6720, DM-6721, and DM-6722 | 0 hours (morning pre-dose), 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Data for Cmax up to Day 56 was collected on Days 1, 14, 28 and 56. |
| Primary | Area Under the Plasma Concentration Curve From 0 to 24 Hours (AUC0-24h) for DM-6704, DM-6705, DM-6706, DM-6717, DM-6718, DM-6720, DM-6721, and DM-6722 | 0 hours (morning pre-dose), 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Data for AUC0-24h up to Day 56 was collected on Days 1, 14, 28 and 56. |
| Primary | Accumulation Ratio for Cmax (Rac[Cmax]) for DM-6704, DM-6705, DM-6706, DM-6717, DM-6718, DM-6720, DM-6721, and DM-6722 | 0 hours (morning pre-dose), 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Data for Rac (Cmax) up to Day 56 was to be collected on Days 1, 14, 28 and 56. Rac (Cmax) on Days 14, 28 or 56 compared to Cmax on Day 1 was to be computed. Due to limited measurable data on Day 1 for delamanid metabolites, pharmacokinetic (PK) analysis was not conducted on Day 1 data for delamanid metabolites, and data for Rac (Cmax) was not available. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Sputum Culture Conversion (SCC) Using the Mycobacteria Growth Indicator Tube (MGIT) System | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 84) | Modified Intent-to-Treat (MITT) Population included all participants who had sputum cultures positive for multidrug resistant tuberculosis (MDR TB) at baseline (Day -1 and/or Day 1) using the MGIT system. | percentage of participants | NUMBER |
| PRIMARY | Tmax 1 and 2: Time to Maximal Peak Concentration (Tmax) for Delamanid Following First and Second Daily Dose | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | All randomized participants who received at least one dose of study medication. Number analyzed is the number of participants with data available for analysis at the given time point. | hours | MEDIAN |
| PRIMARY | Cmax 1 and 2: Maximal Peak Concentration (Cmax) for Delamanid Following First and Second Daily Dose | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | All randomized participants who received at least one dose of study medication. Number analyzed is the number of participants with data available for analysis at the given time point. | nanograms (ng)/mL | MEAN |
| PRIMARY | Area Under the Plasma Concentration Curve From 0 to 24 Hours (AUC0-24h) for Delamanid | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | All randomized participants who received at least one dose of study medication. Number analyzed is the number of participants with data available for analysis at the given time point. | hours*nanograms (h*ng)/mL | MEAN |
| PRIMARY | Accumulation Ratio for Cmax (Rac[Cmax]) for Delamanid | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | All randomized participants who received at least one dose of study medication. Number analyzed is the number of participants with data available for analysis at the given time point. | ratio | MEAN |
| PRIMARY | Accumulation Ratio for AUC From Time 0 to 24 Hours (Rac[AUC0-24h]) for Delamanid | Pre-dose, 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | All randomized participants who received at least one dose of study medication. Number analyzed is the number of participants with data available for analysis at the given time point. | ratio | MEAN |
| PRIMARY | Time to Maximal Peak Concentration (Tmax) for Delamanid Metabolite (DM)-6704, DM-6705, DM-6706, DM-6717, DM-6718, DM-6720, DM-6721, and DM-6722 | 0 hours (morning pre-dose), 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | All randomized participants who received at least one dose of study medication. Number analyzed is the number of participants with data available for analysis at the given time point for the specified category. | hours | MEDIAN |
| PRIMARY | Maximal Peak Concentration (Cmax) for DM-6704, DM-6705, DM-6706, DM-6717, DM-6718, DM-6720, DM-6721, and DM-6722 | 0 hours (morning pre-dose), 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | All randomized participants who received at least one dose of study medication. Number analyzed is the number of participants with data available for analysis at the given time point for the specified category. | ng/mL | MEAN |
| PRIMARY | Area Under the Plasma Concentration Curve From 0 to 24 Hours (AUC0-24h) for DM-6704, DM-6705, DM-6706, DM-6717, DM-6718, DM-6720, DM-6721, and DM-6722 | 0 hours (morning pre-dose), 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | All randomized participants who received at least one dose of study medication. Number analyzed is the number of participants with data available for analysis at the given time point for the specified category. | h*ng/mL | MEAN |
| PRIMARY | Accumulation Ratio for Cmax (Rac[Cmax]) for DM-6704, DM-6705, DM-6706, DM-6717, DM-6718, DM-6720, DM-6721, and DM-6722 | 0 hours (morning pre-dose), 2, 3, 4, 10 (pre-evening dose), 12, 13, 14 and 24 hours post-dose up to Day 56 | Due to limited measurable data as the metabolite concentration was below the level of detection on Day 1 for delamanid metabolites, PK analysis was not conducted on Day 1 data for delamanid metabolites, and data for Rac (Cmax) was not available. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group592
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Sputum Culture Conversion (SCC) Using the Mycobacteria Growth Indicator Tube (MGIT) System | Delamanid 100 mg BID + OBR | 45.4 | percentage of participants | ||
| Percentage of Participants Who Achieved Sputum Culture Conversion (SCC) Using the Mycobacteria Growth Indicator Tube (MGIT) System | Delamanid 200 mg BID + OBR | 41.9 | percentage of participants | ||
| Percentage of Participants Who Achieved Sputum Culture Conversion (SCC) Using the Mycobacteria Growth Indicator Tube (MGIT) System | Placebo + OBR | 29.6 | percentage of participants | ||
| Tmax 1 and 2: Time to Maximal Peak Concentration (Tmax) for Delamanid Following First and Second Daily Dose | Delamanid 100 mg BID + OBR | Day 1: tmax1 | 4.00 | Full Range 1.85 to 10.0 | hours |
| Tmax 1 and 2: Time to Maximal Peak Concentration (Tmax) for Delamanid Following First and Second Daily Dose | Delamanid 200 mg BID + OBR | Day 1: tmax1 | 4.00 | Full Range 2.00 to 10.0 | hours |
| Tmax 1 and 2: Time to Maximal Peak Concentration (Tmax) for Delamanid Following First and Second Daily Dose | Delamanid 100 mg BID + OBR | Day 1: tmax2 | 14.0 | Full Range 11.7 to 24.0 | hours |
| Tmax 1 and 2: Time to Maximal Peak Concentration (Tmax) for Delamanid Following First and Second Daily Dose | Delamanid 200 mg BID + OBR | Day 1: tmax2 | 14.0 | Full Range 11.9 to 24.0 | hours |
| Tmax 1 and 2: Time to Maximal Peak Concentration (Tmax) for Delamanid Following First and Second Daily Dose | Delamanid 100 mg BID + OBR | Day 14: tmax1 | 3.02 | Full Range 0.00 to 10.0 | hours |
| Tmax 1 and 2: Time to Maximal Peak Concentration (Tmax) for Delamanid Following First and Second Daily Dose | Delamanid 200 mg BID + OBR | Day 14: tmax1 | 3.00 | Full Range 0.00 to 10.0 | hours |
| Tmax 1 and 2: Time to Maximal Peak Concentration (Tmax) for Delamanid Following First and Second Daily Dose | Delamanid 100 mg BID + OBR | Day 14: tmax2 | 14.0 | Full Range 11.9 to 24.0 | hours |
1 to 10 of 592Source ClinicalTrials.gov
See all 592 results by groupParticipant flow15
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 | 161 | |
| Overall Study | STARTED | Delamanid 200 mg BID + OBR | 160 | |
| Overall Study | STARTED | Placebo + OBR | 160 | |
| Overall Study | Modified Intent-to-Treat (MITT) | Delamanid 100 mg BID + OBR | 141 | |
| Overall Study | Modified Intent-to-Treat (MITT) | Delamanid 200 mg BID + OBR | 136 | |
| Overall Study | Modified Intent-to-Treat (MITT) | Placebo + OBR | 125 | |
| Overall Study | MITT (Solid Culture) | Delamanid 100 mg BID + OBR | 119 | |
| Overall Study | MITT (Solid Culture) | Delamanid 200 mg BID + OBR | 115 | |
| Overall Study | MITT (Solid Culture) | Placebo + OBR | 113 | |
| Overall Study | COMPLETED | Delamanid 100 mg BID + OBR | 143 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events264
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 | Anaemia | Blood and lymphatic system disorders | Delamanid 100 mg BID + OBR | 15 | 161 | |
| other | Anaemia | Blood and lymphatic system disorders | Delamanid 200 mg BID + OBR | 8 | 160 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + OBR | 14 | 160 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Delamanid 100 mg BID + OBR | 7 | 161 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Delamanid 200 mg BID + OBR | 11 | 160 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Placebo + OBR | 15 | 160 | |
| other | Reticulocytosis | Blood and lymphatic system disorders | Delamanid 100 mg BID + OBR | 19 | 161 | |
| other | Reticulocytosis | Blood and lymphatic system disorders | Delamanid 200 mg BID + OBR | 20 | 160 | |
| other | Reticulocytosis | Blood and lymphatic system disorders | Placebo + OBR | 17 | 160 | |
| other | Palpitations | Cardiac disorders | Delamanid 100 mg BID + OBR | 13 | 161 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Delamanid 100 mg BID + OBR | 0 | 161 |
| Total, all-cause mortality | Delamanid 200 mg BID + OBR | 1 | 160 |
| Total, all-cause mortality | Placebo + OBR | 0 | 160 |
| Total, other adverse events | Delamanid 100 mg BID + OBR | 145 | 161 |
| Total, other adverse events | Delamanid 200 mg BID + OBR | 148 | 160 |
| Total, other adverse events | Placebo + OBR | 147 | 160 |
| Total, serious adverse events | Delamanid 100 mg BID + OBR | 16 | 161 |
| Total, serious adverse events | Delamanid 200 mg BID + OBR | 20 | 160 |
| Total, serious adverse events | Placebo + OBR | 14 | 160 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22670901 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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