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The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole 20 mg | Experimental | Esomeprazole 20 mg once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole 20 mg | Drug | Esomeprazole 20 mg once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period | up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | up to 4 weeks after treatment | |
| Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment | up to 12 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naotsugu Oyama | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ōita | Japan | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23530709 | Derived | Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs. BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54. |
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Out of 395 enrolled participants, 130 participants were registered and 265 participants were not registered. The major reasons of no registration were 'Incorrect enrollment' (247 participants) and 'Voluntary discontinuation by participant' (18 participants).
First participant enrolled 2 Oct 07. Last completed 8 Sept 09. 395 enrolled, 130 registered in study. All registered were included in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy, safety analysis set for summaries of safety variables.
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole 20mg | Esomeprazole 20 mg once daily oral |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment | up to 24 weeks after treatment |
| Saitama |
| Japan |
| Research Site | Tokyo | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole 20mg | Esomeprazole 20 mg once daily oral |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex/Gender, Customized | Number | Participants |
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| 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 | Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | Posted | Number | Participants | up to 4 weeks after treatment |
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| Secondary | Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment | Posted | Number | participants | up to 12 weeks after treatment |
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| Secondary | Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment | Posted | Number | participants | up to 24 weeks after treatment |
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| Primary | Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period | Posted | Number | Participants | up to 52 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 | Esomeprazole 20mg | Esomeprazole 20 mg once daily oral | 14 | 130 | 123 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rheumatoid Arthritis Aggravated | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Osteoarthritis Deterioration | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Campylobacter Intestinal Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Benign Salivary Gland Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
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| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Stomach Discomfort | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
| 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 |
|---|---|
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