Peptic Ulcer
Conditions
Keywords
aspirin, peptic ulcer
Brief summary
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
Detailed description
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.
Interventions
DRUGaspirin
aspirin, 100 mg, qd x 8 weeks
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aspirin users who have a peptic ulcer confirmed by endoscopy
Exclusion criteria
* serious medical illness (including cardiovascular events within 6 months before endoscopy) * acute gastrointestinal bleeding * a history of gastric or duodenal surgery * allergic to the study drugs * require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Whom Peptic Ulcer Was Healed | 8 weeks | Number of participants in whom peptic ulcer was healed at week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Deveoping Peptic Ulcer Bleeding | 8 weeks | Number of participants deveoping peptic ulcer bleeding during 8-week study period |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole esomeprazole (40 mg/day) for 8 weeks | 89 |
| Esomeprazole Plus Aspirin esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
aspirin: aspirin, 100 mg, qd x 8 weeks | 89 |
| Total | 178 |
Baseline characteristics
| Characteristic | Esomeprazole Plus Aspirin | Esomeprazole | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 63 Participants | 68 Participants | 131 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 21 Participants | 47 Participants |
| Age, Continuous | 69.9 years STANDARD_DEVIATION 12.4 | 70.0 years STANDARD_DEVIATION 11 | 69.9 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment Taiwan | 89 participants | 89 participants | 178 participants |
| Sex: Female, Male Female | 37 Participants | 36 Participants | 73 Participants |
| Sex: Female, Male Male | 52 Participants | 53 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 89 | 2 / 89 |
| serious Total, serious adverse events | 0 / 89 | 0 / 89 |
Outcome results
Primary
Number of Participants in Whom Peptic Ulcer Was Healed
Number of participants in whom peptic ulcer was healed at week 8
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole | Number of Participants in Whom Peptic Ulcer Was Healed | 66 participants |
| Esomeprazole Plus Aspirin | Number of Participants in Whom Peptic Ulcer Was Healed | 66 participants |
Secondary
Number of Participants Deveoping Peptic Ulcer Bleeding
Number of participants deveoping peptic ulcer bleeding during 8-week study period
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole | Number of Participants Deveoping Peptic Ulcer Bleeding | 0 participants |
| Esomeprazole Plus Aspirin | Number of Participants Deveoping Peptic Ulcer Bleeding | 0 participants |