Conditions: Stomach Ulcer Duodenal Ulcer
Keywords: Curling Ulcer Gastric Ulcer Aspirin Acetylsalicylic Acid Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 461
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.

Detailed description:
In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. While low-dose aspirin is effective in these cases, its use sometimes causes gastric and duodenal ulcers which can lead to gastrointestinal bleeding, and in worse cases may lead to death.

The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily low dose aspirin therapy.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Lansoprazole intervention 2: Gefarnate
Intervention descriptions: intervention 1: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months. intervention 2: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.

Protocol document: