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The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | Esomeprazole 20 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 20mg once daily oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period | The absence of gastric and/or duodenal ulcer throughout the treatment period | each visit up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment | up to 4 weeks |
| Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naotsugu Oyama | AstraZeneca Japan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chiryū | Aichi-ken | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22591121 | Derived | Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti-inflammatory drug-related peptic ulcers in Japanese patients. Aliment Pharmacol Ther. 2012 Jul;36(2):115-25. doi: 10.1111/j.1365-2036.2012.05133.x. Epub 2012 May 16. |
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Out of 1246 enrolled participants, 343 participants were randomised and 903 participants were not randomised. The major reasons of no randomisation were 'Did not meet eligibility criteria' (877 participants) and 'Voluntary discontinuation by participant' (24 participants).
343 randomised participants 341 in Full Analysis set and safety analysis set. Full set used for summaries of baseline char. and efficacy variables. Safety set used for summaries of safety variables. 2 excluded, took no investigational drug or had protocol deviation. 173 Esomeprazole 20 and 168 placebo had baseline information and were summarised.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Esomeprazole 20 mg | Esomeprazole 20 mg once daily oral |
| FG001 | Comparater: Placebo | Placebo once daily oral |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
once daily oral |
|
The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
| up to 12 weeks |
| Seto |
| Aichi-ken |
| Japan |
| Research Site | Yotukaido | Chiba | Japan |
| Research Site | Miyaodai | Fukuoka | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Akashi | HYOGOi | Japan |
| Research Site | Itami | Hyōgo | Japan |
| Research Site | Koto | Hyōgo | Japan |
| Research Site | Nishinomiya | Hyōgo | Japan |
| Research Site | Hitachi | Ibaragi | Japan |
| Research Site | Morioka | Iwate | Japan |
| Research Site | Sagamihara | Kanagawa | Japan |
| Research Site | Yokohama | Kanagawa | Japan |
| Research Site | Kōtari | Kyoto | Japan |
| Research Site | Kyoto | Kyoto | Japan |
| Research Site | Chiisagata | Nagano | Japan |
| Research Site | Matsumoto | Nagano | Japan |
| Research Site | Nagano | Nagano | Japan |
| Research Site | Sasebo | Nagasaki | Japan |
| Research Site | Beppu | Oita Prefecture | Japan |
| Research Site | Ōita | Oita Prefecture | Japan |
| Research Site | Ibara | Okayama-ken | Japan |
| Research Site | Hirakata | Osaka | Japan |
| Research Site | Osaka | Osaka | Japan |
| Research Site | Sakai | Osaka | Japan |
| Research Site | Suita | Osaka | Japan |
| Research Site | Takatsuki | Osaka | Japan |
| Research Site | Kawagoe | Saitama | Japan |
| Research Site | Saitama | Saitama | Japan |
| Research Site | Fukuroi | Shizuoka | Japan |
| Research Site | Hamamatsu | Shizuoka | Japan |
| Research Site | Izunokuni | Shizuoka | Japan |
| Research Site | Maikinohara | Shizuoka | Japan |
| Research Site | Shizuoka | Shizuoka | Japan |
| Research Site | Yaizu | Shizuoka | Japan |
| Research Site | Shimotsuke | Tochigi | Japan |
| Research Site | Chiyoda City | Tokyo | Japan |
| Research Site | Koto | Tokyo | Japan |
| Research Site | Musashimurayama | Tokyo | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Esomeprazole 20 mg | Esomeprazole 20 mg once daily oral |
| BG001 | Comparater: Placebo | Placebo once daily oral |
| 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, 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 | Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period | The absence of gastric and/or duodenal ulcer throughout the treatment period | Two participants were excluded from these sets because they took no investigational drug or had major protocol deviation. As the result, the numbers of participants for gender baseline were 173 in Esomeprazole 20 mg and 168 in Placebo, respectively. | Posted | Number | Participants | each visit up to 24 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment | Posted | Number | Participants | up to 4 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment | The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment | Posted | Number | Participants | up to 12 weeks |
|
|
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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 oral | 12 | 173 | 134 | 173 | ||
| EG001 | Comparater: Placebo | Placebo once daily oral | 5 | 168 | 124 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colonic Polyp | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Faeces Discoloured | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroduodenal Haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastric Cancer | 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 |
| |
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Medical Device Complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haemorrhagic Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Stomach Discomfort | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Reflux Oesophagitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hepatic Function Abnorma | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| D004381 | Duodenal Ulcer |
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| 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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| Title | Measurements |
|---|---|
|
| >=75 years |
|
| Missing |
|
| Male |
|
| Missing |
|
|
|