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

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ClinicalTrials.gov Identifier: NCT05946135
Recruitment Status : Not yet recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Patients on Treatment With Systemic Steroids Drug: Lansoprazole Drug: Fexuprazan Hydrochloride Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
lansoprazole + placebo for Fexuprazan Hydrochloride
 Drug: Lansoprazole
taking lansoprazole + placebo for Fexuprazan Hydrochloride for 4 weeks
Experimental: Intervention
placebo for lansoprazole + Fexuprazan Hydrochloride
 Drug: Fexuprazan Hydrochloride
taking placebo for lansoprazole + Fexuprazan Hydrochloride for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Changes in baseline gastritis symptoms based on gastritis symptom index at 4 weeks [ Time Frame: baseline and 4 weeks later ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A person who voluntarily signed a consent form
  2. Adult men and women over 20 years of age

  3. 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)

  4. 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

  5. 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.)

  6. 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:

  1. 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
  2. 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
  3. Those who have a history of gastrointestinal malignancies within 5 years of screening (excluding after endoscopic resection of gastric carcinoma or early gastric cancer)
  4. Patients with Barrett's esophagus (over 3 cm), gastroesophageal varices, esophageal stenosis, ulcer stenosis, active peptic ulcers, and acute gastrointestinal bleeding
  5. Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility disorder, and pancreatitis
  6. Patients with eosinophilic esophagitis (if the esophageal biopsy determines that it is not eosinophilic esophagitis, they can participate)
  7. Those who have a history of gastric acid secretion disorders such as Zolinger-Elison syndrome
  8. A person who is currently confirmed positive for Helicobacter pyrroly infection
  9. Persons taking medications contraindicated to clinical trial drug (e.g., atazanavir, nelfinavir, or rilpivirine-containing agents)
  10. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder
  11. Patients with severe renal and liver disorders according to the physician's judgment
  12. A person who disagrees with the appropriate use of contraception by himself/herself or his/her partner during the clinical trial period
  13. Pregnant women or breast feeding women
  14. Any person who has any clinical findings that are deemed medically inappropriate for this trial under the judgment of the research manager
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05946135


Contacts
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Contact: Ji Ye Jung 82-2-2228-0430 stopyes@yuhs.ac

Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Contact: Ji Ye Jung    82-2-2228-0430    stopyes@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Ji Ye Jung Severance Hospital, Division of Pulmonary and Critical Care Medicine
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT05946135    
Other Study ID Numbers: 4-2023-0598
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Lansoprazole
Dexlansoprazole
 Fexuprazan
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action