Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 3)
Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
Participant gender:
Summary
Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a
randomized, double-blind, parallel and positive-controlled trial. They were randomly assigned
into two groups, 10 mg/day ilaprazole and 20 mg/day omeprazole, to be treated for up to four
weeks and be seen at week 1, 2 and 4. The primary endpoint was the ulcer healing rate at week
4. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms
relief was evaluated as secondary end points by using a graded score. Safety and tolerability
were evaluated on basis of clinical assessments.