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

NCT04531475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

  • Reflux Esophagitis

Interventions

DRUG

X842

X842 capsules

DRUG

X842 Placebo

X842 placebo-matching capsules

DRUG

Lansoprazole

Lansoprazole capsules

DRUG

Lansoprazole Placebo

Lansoprazole placebo-matching capsules

Sponsors & Collaborators

  • Jiangsu Sinorda Biomedicine Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Pingsheng Hu, Ph.D · Jiangsu Sinorda Biomedicine Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2020-10-24
Completion
2021-01-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531475 on ClinicalTrials.gov