NCT07079540

The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis

A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Phase III Clinical Study to Evaluate the Efficacy and Safety of X842 Capsules in Patients With Reflux Esophagitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Jiangsu Sinorda Biomedicine Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of X842 Capsules 50 mg compared to Lansoprazole Enteric Capsules for the treatment of reflux esophagitis, and to characterize the population pharmacokinetics of X842 capsules in this patient population.

Detailed description

This study uses a multicenter, randomized, double-blind, double-dummy, active-controlled parallel-group, non-inferiority design to compare the efficacy and safety of X842 capsules (50 mg) in the treatment of reflux esophagitis over 4 to 8 weeks in comparison with lansoprazole enteric-coated capsules(30 mg) . Additionally, the population pharmacokinetics characteristics of X842 capsules in patients with reflux esophagitis is observed.

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: 2021-06-24
• Primary completion: 2022-07-27
• Completion: 2022-12-01
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

53 sites across 1 country: China