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The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Esomeprazole and Omeprazole |
|
| 2 | Experimental | Esomeprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 10mg once daily oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated. |
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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 578 enrolled participants, 564 participants were randomised and 14 participants were not randomised. The reasons of no randomisation were 'Incorrect enrolment' (11 participants) and 'Voluntary discontinuation by participant' (3 participants).
Enrolment 8Jan08-19May09. 564 randomised participants, 563 in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy. SAS for summaries of safety. 1 pt. in Omep. 10 mg excluded as they took no investigational drug. Nos. for gender were 188 in Esom. 20 mg, 188 in Esom. 10 mg and 187 in Omep. 20 mg.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Esomeprazole 20 mg | Esomeprazole 20 mg once daily |
| FG001 | Experimental: Esomeprazole 10 mg | Esomeprazole 10 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Esomeprazole | Drug | 20mg once daily oral administration |
|
|
| Omeprazole | Drug | 10mg once daily oral administration |
|
|
| up to 4 weeks |
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated. | Up to 12 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 | Fukuoika | Fukuoka | Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Kurume | Fukuoka | Japan |
| Research Site | Nukaya | Fukuoka | Japan |
| Research Site | Fukuoka | Fukuolka | Japan |
| Research Site | Kōriyama | Fukushima | 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 10 mg | Omeprazole 10 mg once daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Esomeprazole 20 mg | Esomeprazole 20 mg once daily |
| BG001 | Experimental: Esomeprazole 10 mg | Esomeprazole 10 mg once daily |
| BG002 | Comparator: Omeprazole 10 mg | Omeprazole 10 mg 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 | 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug. | 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 | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated. | Posted | Number | Participants | up to 4 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated. | Posted | Number | Participants | Up to 24 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated. | Posted | Number | Participants | Up to 12 weeks |
|
|
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1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
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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 20 mg | Esomeprazole 20 mg once daily | 5 | 188 | 71 | 188 | ||
| EG001 | Experimental: Esomeprazole 10 mg | Esomeprazole 10 mg once daily | 4 | 188 | 69 | 188 | ||
| EG002 | Comparator: Omeprazole 10 mg | Omeprazole 10 mg once daily | 1 | 187 | 34 | 187 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colonic polyp | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | 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 |
|
| >=75 |
|
| Missing |
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| Male |
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| Missing |
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