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The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis

NCT07079540 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2025-07-23

No results posted yet for this study

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.

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
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2022-07-27
Completion
2022-12-01

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 NCT07079540 on ClinicalTrials.gov