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Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids

NCT05946135 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-13

No results posted yet for this study

Summary

* This clinical trial is conducted as a double-blind, randomized, and active drug control clinical trial. If the screening results determine that the selection/exclusion criteria are met, the clinical trial drugs are randomly assigned at a 1:1 ratio of the Pexuprazan 40 mg and the Lansoprazole 15 mg dose group and taken for 4 weeks.
* Gastritis symptoms are evaluated four weeks after baseline (Visit1) and clinical drug administration (Visit2), and if it is determined that gastritis is necessary according to the medical team's judgment due to gastrointestinal symptoms during the study participation period, endoscopy is performed to check whether gastritis occurs.

Conditions

  • Patients on Treatment With Systemic Steroids

Interventions

DRUG

Lansoprazole

taking lansoprazole + placebo for Fexuprazan Hydrochloride for 4 weeks

DRUG

Fexuprazan Hydrochloride

taking placebo for lansoprazole + Fexuprazan Hydrochloride for 4 weeks

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Ji Ye Jung · Severance Hospital, Division of Pulmonary and Critical Care Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2025-09-08
Completion
2025-09-08

Countries

  • South Korea

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 NCT05946135 on ClinicalTrials.gov