drugset / Trial / NCT02847455

Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients

NCT02847455

Phase 2/3 Completed 408 enrolled Livzon Pharmaceutical Group Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into three groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of ilaprazole, 5, 10 mg/day, and one of Rabeprazole 10 mg/day as positive control. 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
2008-08
Primary completion
2009-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ilaprazole Small molecule 5 mg Oral
Subject Ilaprazole Small molecule 10 mg Oral
Comparator Rabeprazole Small molecule 10 mg Oral

Indications