Phase 4
N=178
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Peptic Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01353144 ↗Enrolled (actual)
178
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Number of Participants in Whom Peptic Ulcer Was Healed — 66; 66 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- aspirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kaohsiung Veterans General Hospital.
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Whom Peptic Ulcer Was Healed |
66; 66 | — |
| SECONDARY Number of Participants Deveoping Peptic Ulcer Bleeding |
0; 0 | — |
Summary
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01353144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.