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Sponsor Terminated
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Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Tetomilast | Experimental |
| |
| 2 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tetomilast | Drug | Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1) | The analysis of the change from Baseline to Week 104 (last observation carried forward [LOCF]) in trough FEV1 is presented below. | Baseline to Week 104 |
| Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | The analysis of the change from Baseline to Week 104 (LOCF) in the 20th percentile of lung density voxels (expressed in Hounsfield unit [HU] using quantitative HCRT) by visit and lung region is presented below. | Baseline to Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Trough FEV1 From Baseline to Week 104 | The percent change for the pulmonary function tests (PFT) from baseline was calculated for each study week as follows: % change from baseline = ([value at Week X - value at baseline] /value at baseline) x 100. | Baseline to Week 104 |
| Density Mask Score Based on Specified Thresholds Including -950 HU |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Lung Health Center | Birmingham | Alabama | 35294 | United States | ||
| Los Angeles Biomedical Institute |
Prior to randomization, each participant was in a 28- to 35-day screening period. Placebo was given for 14 days and a daily diary of symptom scores and actuations of albuterol/ipratropium bromide were collected.
Of the 84 participants treated in the trial, 38 completed the trial and 10 participants were ongoing at the time the sponsor discontinued the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tetomilast 50 mg | Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks. |
| FG001 | Placebo | Participants were administered matching placebo for 104 weeks (2 years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | Placebo for 104 weeks (2 years) |
|
The density mask score is defined as the percentage of lung density voxels that lie below a specified threshold in the lung region of interest. The higher the percentage of the participant's lung density voxels that lie below a specified threshold, the higher the level of the participant's emphysema in the lung region under consideration. Changes in the density mask score was assessed using only a single density mask threshold of -950 HU. |
| Baseline and Week 104 |
| Rate of Change in the 20th Percentile of Lung Density Voxels Expressed in HU Units for the Whole Lung (Whole Right + Whole Left) From Baseline to Week 104 | The rate of change in lung density was calculated as the change in the 20th percentile of lung density voxels divided by the duration between the dates of measurement (month or year) where applicable. For example, if HRCT measurements are available over a span of 2 years, the annual rate of change was calculated as the difference over the 2 years divided by 2, where years between scans is given by years= floor(data of last scan - date of first scan + 1)/365.25. | Baseline to Week 104 |
| Observed Rate of Change in Emphysema From Baseline to Week 104 | The level of emphysema (g/L) within in a lung region is defined as the value of the selected percentile (10th, 15th, or 20th) in HU + 1000. The rate of change in the emphysema from baseline was calculated as the change in the level of emphysema from baseline to the specified visit divided by the time in years between the baseline and specified visit (i.e., [date of visit - date of baseline visit + 1]/365.25). | Baseline to Week 104 |
| Change From Baseline to Week 104 in Cumulative Frequency of HU | The area under the curve (AUC) is defined as the cumulative voxel frequency in HU (ie, the value of the density mask denominator). Blood samples (4 mL) for pharmacokinetic analysis were collected for the determination of plasma OPC-6535 concentrations at Predose on Day 1 and Weeks 26, 52, 78 and 104. | Baseline and Week 104 |
| Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV]) | Change from baseline in CT-derived lung volumes TLC and RV are presented in the below outcome data table. | Baseline to Week 104 |
| Change From Baseline to Week 104 in Trough RV/TLC | Change from Baseline in Trough RV/TLC is presented in the below outcome data table. | Baseline to Week 104 |
| Change From Baseline to Week 104 in Trough Inspiratory Capacity | Change from Baseline in Trough Inspiratory Capacity is presented in the below outcome data table. | Baseline toWeek 104 |
| Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth) | Change from baseline in trough FRCpleth is presented in the below outcome data table. | Baseline to Week 104 |
| Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco) | Change from Baseline in DLco is presented in the below outcome data table. | Baseline to Week 104 |
| Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw) | Change from baseline in sRaw and sGaw is presented in the below outcome data table. | Baseline to Week 104 |
| Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum | Participants used the Breathlessness, Cough, and Sputum Scale (BCSS) as the diary to daily monitor and rate their symptoms of difficulty breathing, cough, and sputum. The scale allows patients to rate each symptom on a scale of 0 (no difficultly for breathing and sputum, or unaware of coughing) to 4 (an almost constant problem for breathing and sputum, or almost constant for cough). | Baseline to Week 104 |
| Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications | Participants recorded rescue medication use (albuterol and/or ipratropium bromide) in a rescue medication log. | Baseline to Week 104 |
| Percentage of Participants With COPD Exacerbations by Group at Week 104 | For the COPD exacerbations, baseline is defined as Randomization (Day 1). COPD exacerbations, defined as an acute worsening of COPD symptoms, were classified as being in one of 3 levels: Level I (can by self-managed by the participant); Level II (requires a physician visit), or Level III (requires a hospital visit). | Baseline and Week 104 |
| Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher) | Percentage of participants experiencing a COPD exacerbation in a level 2 or higher are presented in the below outcome data table. | Baseline and Week 104 |
| Torrance |
| California |
| 90502 |
| United States |
| Pulmonary Disease Specialist/PDS Research | Kissimmee | Florida | 34741 | United States |
| Well Pharma Medical Research | Miami | Florida | 33143 | United States |
| Florida Premier Research Institute | Winter Park | Florida | 32789 | United States |
| Georgia Clinical Research | Austell | Georgia | 30106 | United States |
| Illinios Lung Institute | Peoria | Illinois | 61606 | United States |
| University of Louisville, Pulmonary Division | Louisville | Kentucky | 40202 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Texas Institute of Chest and Sleep Disorders, PA | Houston | Texas | 77034 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| Pulmonary Associates of Richmond | Richmond | Virginia | 23225 | United States |
| Multicare Pulmonary Specialist | Tacoma | Washington | 98405 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population included all randomized participants who had received study medication. Participants in this population were used for all demographic and safety summaries. Participants were analyzed based on the treatment which they had received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tetomilast 50 mg | Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks. |
| BG001 | Placebo | Participants were administered matching placebo for 104 weeks (2 years) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1) | The analysis of the change from Baseline to Week 104 (last observation carried forward [LOCF]) in trough FEV1 is presented below. | The Intent-to-Treat (ITT) population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable High-resolution computed tomography (HRCT) scan. | Posted | Mean | Standard Deviation | L | Baseline to Week 104 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | The analysis of the change from Baseline to Week 104 (LOCF) in the 20th percentile of lung density voxels (expressed in Hounsfield unit [HU] using quantitative HCRT) by visit and lung region is presented below. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 43 and 25 respectively. | Posted | Mean | Standard Deviation | Hounsfield unit/year | Baseline to Week 104 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Trough FEV1 From Baseline to Week 104 | The percent change for the pulmonary function tests (PFT) from baseline was calculated for each study week as follows: % change from baseline = ([value at Week X - value at baseline] /value at baseline) x 100. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 28 and 18 respectively. | Posted | Mean | Standard Deviation | percentage change | Baseline to Week 104 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Density Mask Score Based on Specified Thresholds Including -950 HU | The density mask score is defined as the percentage of lung density voxels that lie below a specified threshold in the lung region of interest. The higher the percentage of the participant's lung density voxels that lie below a specified threshold, the higher the level of the participant's emphysema in the lung region under consideration. Changes in the density mask score was assessed using only a single density mask threshold of -950 HU. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively. | Posted | Mean | Standard Deviation | Hounsfield unit | Baseline and Week 104 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Change in the 20th Percentile of Lung Density Voxels Expressed in HU Units for the Whole Lung (Whole Right + Whole Left) From Baseline to Week 104 | The rate of change in lung density was calculated as the change in the 20th percentile of lung density voxels divided by the duration between the dates of measurement (month or year) where applicable. For example, if HRCT measurements are available over a span of 2 years, the annual rate of change was calculated as the difference over the 2 years divided by 2, where years between scans is given by years= floor(data of last scan - date of first scan + 1)/365.25. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 46 and 26 respectively. | Posted | Mean | Standard Deviation | Hounsfield unit/year | Baseline to Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Observed Rate of Change in Emphysema From Baseline to Week 104 | The level of emphysema (g/L) within in a lung region is defined as the value of the selected percentile (10th, 15th, or 20th) in HU + 1000. The rate of change in the emphysema from baseline was calculated as the change in the level of emphysema from baseline to the specified visit divided by the time in years between the baseline and specified visit (i.e., [date of visit - date of baseline visit + 1]/365.25). | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively. | Posted | Mean | Standard Deviation | g/L | Baseline to Week 104 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 104 in Cumulative Frequency of HU | The area under the curve (AUC) is defined as the cumulative voxel frequency in HU (ie, the value of the density mask denominator). Blood samples (4 mL) for pharmacokinetic analysis were collected for the determination of plasma OPC-6535 concentrations at Predose on Day 1 and Weeks 26, 52, 78 and 104. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively. | Posted | Mean | Standard Deviation | Hounsfield unit*hour | Baseline and Week 104 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV]) | Change from baseline in CT-derived lung volumes TLC and RV are presented in the below outcome data table. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 22 and 16 respectively. | Posted | Mean | Standard Deviation | mL | Baseline to Week 104 |
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| Secondary | Change From Baseline to Week 104 in Trough RV/TLC | Change from Baseline in Trough RV/TLC is presented in the below outcome data table. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were n= 21 and 14 respectively. | Posted | Mean | Standard Deviation | unitless | Baseline to Week 104 |
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| Secondary | Change From Baseline to Week 104 in Trough Inspiratory Capacity | Change from Baseline in Trough Inspiratory Capacity is presented in the below outcome data table. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 25 and 14 respectively. | Posted | Mean | Standard Deviation | mL | Baseline toWeek 104 |
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| Secondary | Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth) | Change from baseline in trough FRCpleth is presented in the below outcome data table. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively. | Posted | Mean | Standard Deviation | mL | Baseline to Week 104 |
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| Secondary | Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco) | Change from Baseline in DLco is presented in the below outcome data table. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively. | Posted | Mean | Standard Deviation | mmoL/min/kPA | Baseline to Week 104 |
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| Secondary | Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw) | Change from baseline in sRaw and sGaw is presented in the below outcome data table. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively. | Posted | Mean | Standard Deviation | kPa.sec | Baseline to Week 104 |
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| Secondary | Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum | Participants used the Breathlessness, Cough, and Sputum Scale (BCSS) as the diary to daily monitor and rate their symptoms of difficulty breathing, cough, and sputum. The scale allows patients to rate each symptom on a scale of 0 (no difficultly for breathing and sputum, or unaware of coughing) to 4 (an almost constant problem for breathing and sputum, or almost constant for cough). | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 13 and 9 respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 104 |
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| Secondary | Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications | Participants recorded rescue medication use (albuterol and/or ipratropium bromide) in a rescue medication log. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 14 and 9 respectively. | Posted | Mean | Standard Deviation | number of puffs | Baseline to Week 104 |
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| Secondary | Percentage of Participants With COPD Exacerbations by Group at Week 104 | For the COPD exacerbations, baseline is defined as Randomization (Day 1). COPD exacerbations, defined as an acute worsening of COPD symptoms, were classified as being in one of 3 levels: Level I (can by self-managed by the participant); Level II (requires a physician visit), or Level III (requires a hospital visit). | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. | Posted | Number | percentage of participants | Baseline and Week 104 |
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| Secondary | Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher) | Percentage of participants experiencing a COPD exacerbation in a level 2 or higher are presented in the below outcome data table. | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. | Posted | Number | percentage of participants | Baseline and Week 104 |
|
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Adverse events were reported from the signing of the informed consent, throughout the 104 week treatment period until the follow-up visit of 14 (+2) days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tetomilast 25 mg | Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks. | 13 | 51 | 30 | 51 | ||
| EG001 | Placebo | Participants were administered matching placebo for 104 weeks (2 years) | 12 | 33 | 23 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Colostomy infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chronic obstrutive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Carotid artery restenosis | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chronic obstrictive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
This trial was terminated early, not due to a safety concern, but due to a business decision to cease development of the tetolimast clinical program.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs | Otsuka Pharmaceutical Development and Commercialization, Inc. | 800 562-3974 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C108965 | tetomilast |
Not provided
Not provided
Not provided
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