Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study to evaluate the effect of preventing recurrence of gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose aspirin and thereby examine the superiority of E3810 over Teprenone.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E3810 5 mg | Experimental |
| |
| E3810 10 mg | Experimental |
| |
| Teprenone 150 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E3810 | Drug | E3810 5 mg/day Group: Orally administered E3810 5 mg tablets and E3810 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Recurrent Rates of Gastric or Duodenal Ulcers | Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Bleeding Ulcers | 24 weeks |
Not provided
Inclusion Criteria
Exclusion Criteria
-Confirmed to have acute gastro duodenal mucosal lesions, gastric or duodenal ulcer, or upper gastrointestinal (esophagus, stomach, duodenum) bleeding Confirmed to have reflux esophagitis or long segment Barrett's esophagus
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nobuyuki Sugisaki | Japan/Asia Clinical Research Product Creation Unit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasugai | Aichi-ken | Japan | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rabeprazole 5 mg | Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal. |
| FG001 | Rabeprazole 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| E3810 | Drug | E3810 10 mg Group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal. |
|
| Teprenone | Drug | Teprenone 150 mg/day Group: Orally administered E3810 5 mg placebo tablets and 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg capsules three times daily after each meal. |
|
| Nagoya |
| Aichi-ken |
| Japan |
| Ichikawa | Chiba | Japan |
| Chikushino-shi | Fukuoka | Japan |
| Fukuoka | Fukuoka | Japan |
| Kitakyushu | Fukuoka | Japan |
| Koga | Fukuoka | Japan |
| Gifu | Gifu | Japan |
| Maebashi | Gunma | Japan |
| Asahikawa | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Tomakomai | Hokkaido | Japan |
| Itami | Hyōgo | Japan |
| Kobe | Hyōgo | Japan |
| Hitachi | Ibaraki | Japan |
| Fujisawa | Kanagawa | Japan |
| Kawasaki | Kanagawa | Japan |
| Sagamihara | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Kochi | Kochi | Japan |
| Hitoyoshi | Kumamoto | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Ebino | Miyazaki | Japan |
| Miyazaki | Miyazaki | Japan |
| Chikuma | Nagano | Japan |
| Matsumoto | Nagano | Japan |
| Nagano | Nagano | Japan |
| Suzaka | Nagano | Japan |
| Nagasaki | Nagasaki | Japan |
| Beppu | Oita Prefecture | Japan |
| Ōita | Oita Prefecture | Japan |
| Yufu | Oita Prefecture | Japan |
| Daitō | Osaka | Japan |
| Hirakata | Osaka | Japan |
| Matsubara | Osaka | Japan |
| Osaka | Osaka | Japan |
| Takatsuki | Osaka | Japan |
| Yao | Osaka | Japan |
| Karatsu | Saga-ken | Japan |
| Saga | Saga-ken | Japan |
| Ureshino | Saga-ken | Japan |
| Izumo | Shimane | Japan |
| Hamamatsu | Shizuoka | Japan |
| Shizuoka | Shizuoka | Japan |
| Ohtawara | Tochigi | Japan |
| Mitaka | Tokyo | Japan |
| Setagaya City | Tokyo | Japan |
| Shinjuku | Tokyo | Japan |
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal. |
| FG002 | Teprenone 150 mg | Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rabeprazole 5 mg | Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal. |
| BG001 | Rabeprazole 10 mg | Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal. |
| BG002 | Teprenone 150 mg | Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal. |
| BG003 | 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 |
| ||||||||||||||||
| Antiplatelet Drug or Anticoagulant Drug | Number | Participants |
| ||||||||||||||||
| Daily Dose of Low-Dose Aspirin | Number | Participants |
| ||||||||||||||||
| Diagnostic Test of H.pylori. (IgG Antibody) | Number | Participants |
| ||||||||||||||||
| Primary Disease | Percutaneous Transluminal Coronary Angioplasty is represented as PTCA. | Number | 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Cumulative Incidence of Bleeding Ulcers | Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available. | Posted | Number | 95% Confidence Interval | Events/100 participants/24 weeks | 24 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Cumulative Recurrent Rates of Gastric or Duodenal Ulcers | Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved. | Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available. | Posted | Number | 95% Confidence Interval | Events/100 participants/24 weeks | 24 weeks |
|
24 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rabeprazole 5 mg | Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal. | 10 | 156 | 48 | 156 | ||
| EG001 | Rabeprazole 10 mg | Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal. | 6 | 157 | 46 | 157 | ||
| EG002 | Teprenone 150 mg | Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal. | 10 | 158 | 41 | 158 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nobuyuki Sugisaki | Eisai Co., Ltd. | +81-3-3817-3908 | 3908 |
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| C031049 | geranylgeranylacetone |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| No |
|
| 100 mg |
|
| Negative |
|
| Angina Pectoris (No) |
|
| Myocardial Infarction (Yes) |
|
| Myocardial Infarction (No) |
|
| Ischemic Cerebrovascular Disease (Yes) |
|
| Ischemic Cerebrovascular Disease (No) |
|
| Coronary Arterial Bypass Grafting or PTCA (Yes) |
|
| Coronary Arterial Bypass Grafting or PTCA (No) |
|
| Other (Yes) |
|
| Other (No) |
|
|
|
|