Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Intervention: Vonoprazan; Lansoprazole
Intervention description: Vonoprazan fumarate 10 mg or 20 mg capsules; Lansoprazole 15 mg or 30 mg capsules
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Esophagitis

Summary:

      The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and
      the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in
      patients receiving maintenance treatment after healed erosive esophagitis (EE), and the
      curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.
    

Eligibility criteria:

        Inclusion Criteria

        Healing Phase:

          1. Participants endoscopically diagnosed with EE of grades A to D by the LA
             Classification Grading System at the start of treatment (Week 0 of the healing phase)

          2. Participants with H. pylori negative

          3. Participants who, in the opinion of the principal investigator or investigator, are
             capable of understanding the content of the clinical research and complying with the
             research protocol requirements.

          4. Participants who can sign and date an informed consent form and information sheet
             prior to the conduction of the clinical research procedures.

          5. Male or female participants aged 20 years or older at the time of informed consent

          6. Therapeutic category: Ambulatory

             Maintenance Phase:

          7. Participants who have endoscopically confirmed EE healing* (mucous membrane disorder
             is not observed) at completion of the healing phase (Week 4 or 8 of the healing phase)

             * Participants who are classified as grade 0 according to severity classification of
             EE (See Table 9.b)

          8. Participants who have been determined to be appropriate as subjects for maintenance
             treatment of EE by the principal investigator or investigator

        Exclusion Criteria:

        Healing Phase:

          1. Participants with concurrent peptic ulcer (except scarred stage) or Zollinger-Ellison
             syndrome

          2. Participants who received treatment with PPIs (including vonoprazan) within 4 weeks
             (Week -4 to Week 0) prior to the start of healing phase (Week 0 of the healing phase)

          3. Participants with a history of H. pylori eradication.

          4. Participants who have received surgery or treatment affecting gastroesophageal reflux
             (fundoplication or dilation for esophageal stenosis [excluding Schatzki's ring], etc.)

          5. Participants with an esophagus-related complication (eosinophilic esophagitis,
             esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis,
             etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or
             physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with
             Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or
             Barrett's esophagus are allowed to be included.

          6. Participants with clinically apparent hepatic impairment (e.g., AST or ALT levels at
             the time of informed consent: >1.5 times the upper limit of normal (ULN).

          7. Participants with renal impairment or renal failure [creatinine clearance (CCr) ˂30
             mL/min, etc.]

          8. Participants with a history of hypersensitivity or allergy for PPIs.

          9. Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy

         10. Participants with a malignant tumor

         11. Participants who are pregnant, breast-feeding, possibly pregnant, or planning to
             become pregnant

         12. Participants with one of the diseases listed under administration contraindication in
             the vonoprazan or lansoprazole package insert

         13. Participants planning to take prohibited concomitant medications during the research
             period

         14. Participants participating in other clinical studies

         15. Participants who have been determined to be inappropriate as subjects in the study by
             the principal investigator or investigator

             Maintenance Phase:

         16. Participants who have taken PPIs other than the study drug or the control drug during
             the healing phase

         17. Participants who have been determined to be inappropriate as subjects in the study by
             the principal investigator or investigator