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

Primary Purpose

Patients on Treatment With Systemic Steroids

Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lansoprazole
Fexuprazan Hydrochloride
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients on Treatment With Systemic Steroids

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A person who voluntarily signed a consent form Adult men and women over 20 years of age Patients who require systemic steroid treatment of at least 4 weeks of moderate dose (20 mg/day or more based on prednisolone) due to respiratory diseases during screening Patients who are already on steroids can also participate (If there is a gastric protective agent in use, patients should agree to replace it with clinical trial drug) Patients who satisfy both of the following in relation to the evaluation index of gastritis symptoms during screening - Gastritis symptom frequency indicator: 5 points or less - Gastritis symptom intensity indicator: 5 points or less A person who has at least one of the following risk factors for gastric ulcer during screening ① Long-term use of NSAIDs for longer than 12 weeks (NSAIDs should be maintained continuously during the clinical trial.) ② A person who has a history of peptic ulcer in the past ③ 50 years of age or older ④ In combination with low-dose aspirin (aspirin 325 mg/day or less) (Low-dose aspirin should be maintained continuously during the clinical trial.) A person who understand and follow the guidance of the research manager according to the research plan, and who can participate whole period of clinical trial Exclusion Criteria: A person who has a hypersensitivity reaction to the components of this clinical trial drug or benzimidazole-based drug or has a history of clinically significant hypersensitivity reaction A person who has undergone surgery that may affect gastric acid secretion, such as upper gastrointestinal resection, gastric acid secretion inhibition surgery, and gastric mucosal resection Those who have a history of gastrointestinal malignancies within 5 years of screening (excluding after endoscopic resection of gastric carcinoma or early gastric cancer) Patients with Barrett's esophagus (over 3 cm), gastroesophageal varices, esophageal stenosis, ulcer stenosis, active peptic ulcers, and acute gastrointestinal bleeding Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility disorder, and pancreatitis Patients with eosinophilic esophagitis (if the esophageal biopsy determines that it is not eosinophilic esophagitis, they can participate) Those who have a history of gastric acid secretion disorders such as Zolinger-Elison syndrome A person who is currently confirmed positive for Helicobacter pyrroly infection Persons taking medications contraindicated to clinical trial drug (e.g., atazanavir, nelfinavir, or rilpivirine-containing agents) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder Patients with severe renal and liver disorders according to the physician's judgment A person who disagrees with the appropriate use of contraception by himself/herself or his/her partner during the clinical trial period Pregnant women or breast feeding women Any person who has any clinical findings that are deemed medically inappropriate for this trial under the judgment of the research manager

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

lansoprazole + placebo for Fexuprazan Hydrochloride

placebo for lansoprazole + Fexuprazan Hydrochloride

Outcomes

Primary Outcome Measures

Changes in baseline gastritis symptoms based on gastritis symptom index at 4 weeks
To evaluate the effect of preventing gastritis symptoms, changes in gastritis symptoms using gastritis symptom index after 4 weeks compared to baseline were compared. The gastritic symptoms index consisted of 10 items to be questioned about the frequency and degree of symptoms over the past 4 weeks.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
July 6, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05946135
Brief Title
Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids
Official Title
A Randomized, Double-blind, Active Controlled Clinical Trial to Evaluate the Efficacy of Fexuprazan for the Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids (FEAST)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients on Treatment With Systemic Steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
lansoprazole + placebo for Fexuprazan Hydrochloride
Arm Title
Intervention
Arm Type
Experimental
Arm Description
placebo for lansoprazole + Fexuprazan Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
taking lansoprazole + placebo for Fexuprazan Hydrochloride for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Fexuprazan Hydrochloride
Intervention Description
taking placebo for lansoprazole + Fexuprazan Hydrochloride for 4 weeks
Primary Outcome Measure Information:
Title
Changes in baseline gastritis symptoms based on gastritis symptom index at 4 weeks
Description
To evaluate the effect of preventing gastritis symptoms, changes in gastritis symptoms using gastritis symptom index after 4 weeks compared to baseline were compared. The gastritic symptoms index consisted of 10 items to be questioned about the frequency and degree of symptoms over the past 4 weeks.
Time Frame
baseline and 4 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A person who voluntarily signed a consent form Adult men and women over 20 years of age Patients who require systemic steroid treatment of at least 4 weeks of moderate dose (20 mg/day or more based on prednisolone) due to respiratory diseases during screening Patients who are already on steroids can also participate (If there is a gastric protective agent in use, patients should agree to replace it with clinical trial drug) Patients who satisfy both of the following in relation to the evaluation index of gastritis symptoms during screening - Gastritis symptom frequency indicator: 5 points or less - Gastritis symptom intensity indicator: 5 points or less A person who has at least one of the following risk factors for gastric ulcer during screening ① Long-term use of NSAIDs for longer than 12 weeks (NSAIDs should be maintained continuously during the clinical trial.) ② A person who has a history of peptic ulcer in the past ③ 50 years of age or older ④ In combination with low-dose aspirin (aspirin 325 mg/day or less) (Low-dose aspirin should be maintained continuously during the clinical trial.) A person who understand and follow the guidance of the research manager according to the research plan, and who can participate whole period of clinical trial Exclusion Criteria: A person who has a hypersensitivity reaction to the components of this clinical trial drug or benzimidazole-based drug or has a history of clinically significant hypersensitivity reaction A person who has undergone surgery that may affect gastric acid secretion, such as upper gastrointestinal resection, gastric acid secretion inhibition surgery, and gastric mucosal resection Those who have a history of gastrointestinal malignancies within 5 years of screening (excluding after endoscopic resection of gastric carcinoma or early gastric cancer) Patients with Barrett's esophagus (over 3 cm), gastroesophageal varices, esophageal stenosis, ulcer stenosis, active peptic ulcers, and acute gastrointestinal bleeding Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility disorder, and pancreatitis Patients with eosinophilic esophagitis (if the esophageal biopsy determines that it is not eosinophilic esophagitis, they can participate) Those who have a history of gastric acid secretion disorders such as Zolinger-Elison syndrome A person who is currently confirmed positive for Helicobacter pyrroly infection Persons taking medications contraindicated to clinical trial drug (e.g., atazanavir, nelfinavir, or rilpivirine-containing agents) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder Patients with severe renal and liver disorders according to the physician's judgment A person who disagrees with the appropriate use of contraception by himself/herself or his/her partner during the clinical trial period Pregnant women or breast feeding women Any person who has any clinical findings that are deemed medically inappropriate for this trial under the judgment of the research manager
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Ye Jung
Phone
82-2-2228-0430
Email
stopyes@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Ye Jung
Organizational Affiliation
Severance Hospital, Division of Pulmonary and Critical Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Ye Jung
Phone
82-2-2228-0430
Email
stopyes@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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