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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
261
The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products (LXI-15028 50mg active agent + Esomeprazole 40mg matching placebo . If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 8 weeks.
The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products ( LXI-15028 50mg matching placebo + Esomeprazole 40mg active agent ). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 8 weeks.
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Cumulative endoscopic healing rate
Percentage of patients with healing erosion based on the upper Gastrointestinal (GI) endoscopy following 8 weeks of study treatment
Time frame: 4 or 8 weeks after receiving oral doses
Endoscopic healing rate at Week 4
Percentage of patients with healing erosion based on the upper Gastrointestinal (GI) endoscopy following 4 weeks of study treatment
Time frame: 4 week after receiving oral doses
Change of Reflux Disease Questionnaire (RDQ) score for main symptoms
Total score for main symptoms (heartburn and regurgitation) (Total score is the sum of the score of heartburn and regurgitation, the range is 0-20, the higher score indicates the worse sympotom)
Time frame: 4 or 8 weeks after receiving oral doses
Change of Reflux Disease Questionnaire (RDQ) score for subcategory
Score for each Reflux Disease Questionnaire (RDQ) subcategory (heartburn, regurgitation and dyspepsia) (The range is 0-10 for every subcategory score)
Time frame: 4 or 8 weeks after receiving oral doses
Symptom assessment based on subject diary
Percentage of days without main symptoms (heartburn and regurgitation) during 1 week (7 days), 4 weeks and 8 weeks from the initiation of study treatment
Time frame: 4 or 8 weeks after receiving oral doses
Change of Gastro Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score
Change of Gastro Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score of each post-treatment visit from baseline at each post-treatment visit from baseline
Time frame: 4 or 8 weeks after receiving oral doses
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.