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Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers.
Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esomeprazole | No Intervention | esomeprazole (40 mg/day) for 8 weeks | |
| esomeprazole plus aspirin | Active Comparator | esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin | Drug | aspirin, 100 mg, qd x 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Whom Peptic Ulcer Was Healed | Number of participants in whom peptic ulcer was healed at week 8 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Deveoping Peptic Ulcer Bleeding | Number of participants deveoping peptic ulcer bleeding during 8-week study period | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwok-Hung Lai, MD | Kaohsiung Veterans General Hospital. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ho Hospital | Kaohsiung | Taiwan | 807 | Taiwan | ||
| Kaohsiung Veterans General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole | esomeprazole (40 mg/day) for 8 weeks |
| FG001 | Esomeprazole Plus Aspirin | esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole | esomeprazole (40 mg/day) for 8 weeks |
| BG001 | Esomeprazole Plus Aspirin | esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 in Whom Peptic Ulcer Was Healed | Number of participants in whom peptic ulcer was healed at week 8 | Posted | Number | participants | 8 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 | esomeprazole (40 mg/day) for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
The trial was performed in a single country
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ping-I Hsu | Kaohsiung Veterans General Hospital | +886-7-3422121 | 8233 | pihsu@vghks.gov.tw |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Kaohsiung |
| Taiwan |
| 813 |
| Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Participants Deveoping Peptic Ulcer Bleeding | Number of participants deveoping peptic ulcer bleeding during 8-week study period | Posted | Number | participants | 8 weeks |
|
|
|
| 0 |
| 89 |
| 1 |
| 89 |
| EG001 | Esomeprazole Plus Aspirin | esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks | 0 | 89 | 2 | 89 |
| persistent dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| D013272 | Stomach Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |