A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers

Kaohsiung Veterans General Hospital

Status and phase: Completed; Phase 4

Conditions: Peptic Ulcer

Treatments: Drug: aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01353144

VGHKS96-CT4-26

Details and patient eligibility

About

Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

esomeprazole

No Intervention group

Description:

esomeprazole (40 mg/day) for 8 weeks

esomeprazole plus aspirin

Active Comparator group

Description:

esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks

Treatment:

Drug: aspirin