Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis
Status:
Completed
Trial end date:
2019-10-18
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, double-blind, parallel-group, active controlled Phase III
clinical study to evaluate the efficacy and safety of LXI-15028 50 mg comparing with
esomeprazole 40 mg after the treatment of erosive esophagitis in Chinese patients for up to 8
weeks.
Screening-eligible subjects will be randomized into LXI-15028 50mg treatment group or
esomeprazole 40mg treatment group at Visit 2 (Day 0) stratified by LA grade (A or B/C/D) at
baseline according to the ratio of 1:1 and receive study treatment continuously for 4 or 8
weeks. They will start to take the investigational products from the following morning (Day
1) of Visit 2, and start to complete the subject's diary from the day of study treatment
initiation. After 4 weeks of study treatment (treatment period 1), subjects will return to
the study site and complete Visit 3. For the subjects who achieve endoscopic healing at Visit
3, the study treatment will be terminated. The subjects who fail to achieve endoscopic
healing at Visit 3 will receive newly dispensed investigational product after completing the
fasting examinations at Visit 3, and continue another 4 weeks of study treatment (treatment
period 2) and complete Visit 4. All the subjects will be followed up by phone (Visit 5) at
Day 28±3 after the last dose of investigational products.
Phase:
Phase 3
Details
Lead Sponsor:
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.