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This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Esomeprazole 20mg |
|
| 2 | Experimental | Esomeprazole 40mg |
|
| 3 | Active Comparator | Omeprazole 20mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 20mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification". | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maotsugu Oyama, MD, PhD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Akita | Akita | Japan | |||
| Research Site |
Out of 602 enrolled subjects, 572 subjects were randomised and 30 subjects were not randomised. The reasons of no randomisation were 'Incorrect enrollment' (25 subjects) and 'Voluntary discontinuation by Subject' (5 subjects).
First subject enrolled on 11 December 2007. Last subject completed on 12 December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Esomeprazole 40mg | Esomeprazole 40mg once daily |
| FG001 | Experimental: Esomeprazole 20mg | Esomeprazole 20mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Esomeprazole |
| Drug |
40 mg once daily |
|
|
| Omeprazole | Drug | 20mg once daily |
|
|
| 4 weeks |
| Kashiwa |
| Chiba |
| Japan |
| Research Site | Kisarazu | Chiba | Japan |
| Research Site | Kōriyama | Fukishima | Japan |
| Research Site | Nihonmatsu | Fukishima | Japan |
| Research Site | Nishishirakawa | Fukishima | Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Kurume | Fukuoka | Japan |
| Research Site | Nukaya | Fukuoka | Japan |
| Research Site | Shirakawa | Fukushima | Japan |
| Research Site | Sugawa | Fukushima | Japan |
| Research Site | Gifu | Gifu | Japan |
| Research Site | Maebashi | Gunma | Japan |
| Research Site | Yasunaka | Gunma | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Hitachi | Ibaraki | Japan |
| Research Site | Mito | Ibaraki | Japan |
| Research Site | Tsukuba | Ibaraki | Japan |
| Research Site | Sakaidechō | Kagawa-ken | Japan |
| Research Site | Takamatsu | Kagawa-ken | Japan |
| Research Site | Fujisawa | Kanagawa | Japan |
| Research Site | Kawasaki | Kanagawa | Japan |
| Research Site | Sagamihara | Kanagawa | Japan |
| Research Site | Yokohama | Kanagawa | Japan |
| Research Site | Kyoto | Kyoto | Japan |
| Research Site | Shibata | Myagi | Japan |
| Research Site | Kiso | Nagano | Japan |
| Research Site | Matsumoto | Nagano | Japan |
| Research Site | Ōita | Oita Prefecture | Japan |
| Research Site | Fujiidera | Osaka | Japan |
| Research Site | Toyonaka | Osaka | Japan |
| Research Site | Shizuoka | Shizuoka | Japan |
| Research Site | Ohtawara | Tochigi | Japan |
| Research Site | Toshima-ku | Tokayo | Japan |
| Research Site | Adachi City | Tokyo | Japan |
| Research Site | Hachiōji | Tokyo | Japan |
| Research Site | Kiyose | Tokyo | Japan |
| Research Site | Setagaya City | Tokyo | Japan |
| Research Site | Shinagawa | Tokyo | Japan |
| Research Site | Tottori-shi | Tottori | Japan |
| Research Site | Shimonoseki | Yamaguchi | Japan |
| FG002 | Comparator: Omeprazole 20mg | Omeprazole 20mg once daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Esomeprazole 40mg | Esomeprazole 40mg once daily |
| BG001 | Experimental: Esomeprazole 20mg | Esomeprazole 20mg once daily |
| BG002 | Comparator: Omeprazole 20mg | Omeprazole 20mg once daily |
| 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, Customized | Number | Participants |
| ||||||||||||||||
| Sex/Gender, 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 | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification". | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference). | One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses. | Posted | Number | participants | 8 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference). | One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses. | Posted | Number | participants | 4 weeks |
|
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One patient for each treatment group did not take any investigational product.
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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 | Experimental: Esomeprazole 40mg | Esomeprazole 40mg once daily | 0 | 190 | 12 | 190 | ||
| EG001 | Experimental: Esomeprazole 20mg | Esomeprazole 20mg once daily | 1 | 189 | 9 | 189 | ||
| EG002 | Comparator: Omeprazole 20mg | Omeprazole 20mg once daily | 1 | 190 | 16 | 190 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
All PIs were prohibited to disclose all information related to this study withiout AZ approval before this study was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| 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 |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D009853 | Omeprazole |
| 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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| 65 - 74 years |
|
| >= 75 years |
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| Missing |
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| Female |
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| Missing |
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