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The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.
This is a multicenter, randomized, double-blinded study. The efficacy with E3810 20 mg once daily is compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse event, etc., will be compared among 3 groups for safety assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E3810 | Drug | 20 mg taken orally, once a day for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | Grade N indicates a normal appearance of lower esophageal mucosa | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomoki Kubota | New Product Development Dept., Clinical Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagakute | Aichi-ken | Japan | ||||
There was no run-in phase before assignment to E3810 treatment groups in this study.
This study was recruited at 71 centers in Japan during the period of 17-Oct-2008 to 12-Nov-2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | E3810 20 mg Once Daily | E3810 20mg once daily orally for 8 weeks |
| FG001 | E3810 10 mg Twice Daily | E3810 10mg twice daily orally for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| E3810 | Drug | 10 mg, taken orally, twice a day for 8 weeks. |
|
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| E3810 | Drug | 20 mg taken orally, twice a day for 8 weeks. |
|
|
| Nagoya |
| Aichi-ken |
| Japan |
| Akita | Akita | Japan |
| Abiko | Chiba | Japan |
| Kashiwa | Chiba | Japan |
| Yachiyo | Chiba | Japan |
| Chikushino-shi | Fukuoka | Japan |
| Fukuoka | Fukuoka | Japan |
| Omuta | Fukuoka | Japan |
| Tagawa | Fukuoka | Japan |
| Kōriyama | Fukushima | Japan |
| Gifu | Gifu | Japan |
| Hashima | Gifu | Japan |
| Maebashi | Gunma | Japan |
| Hiroshima | Hiroshima | Japan |
| Asahikawa | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Itami | Hyōgo | Japan |
| Nishinomiya | Hyōgo | Japan |
| Hitachi | Ibaraki | Japan |
| Takamatsu | Kagawa-ken | Japan |
| Kagoshima | Kagoshima-ken | Japan |
| Kirishima | Kagoshima-ken | Japan |
| Kawasaki | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Kochi | Kochi | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Ishinomaki | Miyagi | Japan |
| Nagasaki | Nagasaki | Japan |
| Yamatokōriyama | Nara | Japan |
| Beppu | Oita Prefecture | Japan |
| Ōita | Oita Prefecture | Japan |
| Okayama | Okayama-ken | Japan |
| Hirakata | Osaka | Japan |
| Osaka | Osaka | Japan |
| Karatsu | Saga-ken | Japan |
| Saga | Saga-ken | Japan |
| Kusatsu | Shiga | Japan |
| Izumo | Shimane | Japan |
| Matsue | Shimane | Japan |
| Fujieda | Shizuoka | Japan |
| Hamamatsu | Shizuoka | Japan |
| Shimada | Shizuoka | Japan |
| Shizuoka | Shizuoka | Japan |
| Ohtawara | Tochigi | Japan |
| Bunkyo | Tokyo | Japan |
| Setagaya City | Tokyo | Japan |
| Shinagawa | Tokyo | Japan |
| Shinjuku | Tokyo | Japan |
| tabashi City | Tokyo | Japan |
| Yamagata | Yamagata | Japan |
| Hōfu | Yamaguchi | Japan |
| Shimonoseki | Yamaguchi | Japan |
| FG002 | E3810 20 mg Twice Daily | E3810 20mg twice daily orally for 8 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | E3810 20 mg Once Daily | E3810 20mg once daily orally for 8 weeks |
| BG001 | E3810 10 mg Twice Daily | E3810 10mg twice daily orally for 8 weeks |
| BG002 | E3810 20 mg Twice Daily | E3810 20mg twice daily orally for 8 weeks |
| 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 | Full Analysis Population | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | Grade N indicates a normal appearance of lower esophageal mucosa | The primary analysis was on the full analysis set (FAS) population. | Posted | Number | Percentage of Participants | 8 weeks |
|
|
|
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The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
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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 | E3810 20 mg Once Daily | E3810 20 mg once daily orally for 8 weeks | 3 | 112 | 27 | 112 | ||
| EG001 | E3810 10 mg Twice Daily | E3810 10 mg twice daily orally for 8 weeks | 6 | 111 | 25 | 111 | ||
| EG002 | E3810 20 mg | E3810 20 mg twice daily orally for 8 weeks | 5 | 114 | 20 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Intracranial aneurysm | Nervous system disorders |
| |||
| Putamen haemorrhage | Nervous system disorders |
| |||
| Cardiac failure | Cardiac disorders |
| |||
| Coronary artery stenosis | Cardiac disorders |
| |||
| Aortic aneurysm | Vascular disorders |
| |||
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
| |||
| Dermatitis | Skin and subcutaneous tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders |
| |||
| Tendon rupture | Injury, poisoning and procedural complications |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations |
| |||
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Blood thyroid stimulating hormone increased | Investigations |
| |||
| Blood triglycerides increased | Investigations |
|
In the Participant flow section, there is only one "Reason for Not Completed" per participant reported, even if there were multiple reasons.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tomoki Kubota, Study Director | Eisai Co.,Ltd. Eisai Product Creation Systems | +81-3-3817-3908 | t2-kubota@hhc.eisai.co.jp |
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
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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 |
|