NCT04531475

Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis

A Multicenter, Randomized, Double-blind, Double-simulation, Active Comparator-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of X842 Capsules at Different Dosages in Patients With Reflux Esophagitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Jiangsu Sinorda Biomedicine Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules.

Detailed description

It is designed as a multicenter, randomized, double-blind, double-simulation, high and low dose group, active comparator-controlled, parallel-group study to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules.

Conditions

• Reflux Esophagitis

Interventions

Type	Name	Description
DRUG	X842	X842 capsules
DRUG	X842 Placebo	X842 placebo-matching capsules
DRUG	Lansoprazole	Lansoprazole capsules
DRUG	Lansoprazole Placebo	Lansoprazole placebo-matching capsules

Timeline

• Start date: 2020-01-21
• Primary completion: 2020-10-24
• Completion: 2021-01-12
• First posted: 2020-08-28
• Last updated: 2025-07-17

Locations

16 sites across 1 country: China