Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 3)

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.

Timeline

Start

2005-09

Primary completion

2006-02

Completion

2006-05

Publications

• Wang L, Zhou L, Hu H, Lin S, Xia J. Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial. Curr Med Res Opin. 2012 Jan;28(1):101-9. doi: 10.1185/03007995.2011.639353. Epub 2012 Jan 3.

Drugs

Indications