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The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) [Double-Blind Phase] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.
The E3810-J081-309 consisted of two arms: the long-term rabeprazole groups (participants from the rabeprazole 5 or 10 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study) and the newly-initiated rabeprazole groups (participants from the teprenone 150 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rabeprazole 5 mg | Experimental |
| |
| Rabeprazole 10 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole | Drug | Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs. | For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Recurrent Rate of Gastric or Duodenal Ulcers | Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers. |
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Inclusion Criteria
Exclusion Criteria
-Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.
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| 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 | ||||
From a total of 420 participants who completed the E3810-J081-308 (NCT01397448) study, 405 entered the E3810-J081-309 (NCT01398410) study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rabeprazole 5 mg | Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily |
| FG001 | Rabeprazole 10 mg | Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rabeprazole | Drug | Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily |
|
|
| Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase) |
| 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 |
| Kitakyushu | Kitakyushu | 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 |
| Hirakat | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rabeprazole 5 mg | Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily |
| BG001 | Rabeprazole 10 mg | Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily |
| 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 | Percentage of Participants With Treatment Emergent Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs. | The analysis was performed using Safety Analysis Set, defined as all participants who received at least one dose of rabeprazole. | Posted | Number | Percentage of participants | For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Cumulative Recurrent Rate of Gastric or Duodenal Ulcers | Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers. | The analysis was performed using Full Analysis Set, defined as all participants who received at least one dose of rabeprazole, with at least one post-initiation endoscopic assessment results, and showed no ulcers on baseline endoscopy; excluding participants from the newly-initiated rabeprazole groups of study E3810-J081-309. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase) |
|
For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
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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 | Rabeprazole 5 mg | Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily | 33 | 201 | 89 | 201 | ||
| EG001 | Rabeprazole10 mg | Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily | 30 | 204 | 99 | 204 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
| |
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA version 15.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.1 | Systematic Assessment |
| |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.1 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.1 | Systematic Assessment |
| |
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.1 | Systematic Assessment |
| |
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.1 | Systematic Assessment |
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| Brain stem infarction | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
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| Lacunar infarction | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Haemorrhoid operation | Surgical and medical procedures | MedDRA version 15.1 | Systematic Assessment |
| |
| Artery dissection | Vascular disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 15.1 | Systematic Assessment |
|
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| 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 |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| 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 |
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| Male |
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