Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation
Condition: Reflux Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic; Dyssomnias; Parasomnias
Intervention: Vonoprazan
Intervention description: Vonoprazan 20 mg
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to exploratorily evaluate the effect of vonoprazan 20 mg on
      sleep disturbance of patients with reflux esophagitis, who have heartburn and/or
      regurgitation and ≥ 6.0 in the Pittsburgh Sleep Quality Index (PSQI) global score despite the
      maintenance treatment with PPI other than vonoprazan.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants who completed the initial treatment with PPIs (esomeprazole, omeprazole,
             rabeprazole, or lansoprazole) and have received high dose PPIs (esomeprazole 20 mg,
             omeprazole 20 mg, rabeprazole 10 mg, or lansoprazole 30 mg) for more than 8 weeks at
             the time of informed consent as maintenance treatment for LA Classification Grades A
             to D reflux esophagitis.

          2. Participants who have heartburn and/or regurgitation.

          3. Participants with reflux esophagitis related sleep disturbance, fulfilling at least
             one of following in a week before the baseline/start of administration.

               -  Difficulty in falling asleep for > = 3 nights

               -  Nocturnal awaking or early morning awaking for > = 3 nights

          4. Participants whose heartburn and/or regurgitation at the time of informed consent were
             alleviated from initial treatment.

          5. Participants with PSQI global score > = 6.0

          6. Participants who, in the opinion of the investigator, are capable of understanding the
             content of the study and complying with the protocol requirements.

          7. Participants who can sign and date an informed consent form and information sheet
             prior to the initiation of the study procedures.

          8. Male or female participants aged 20 years or older at the time of informed consent.

          9. Therapeutic category: Ambulatory

        Exclusion Criteria:

          1. Participants with Zollinger-Ellison syndrome.

          2. Participants with diseases that affect sleep (chronic obstructive pulmonary disease,
             bronchitis asthma, sleep apnea syndrome, mental disorder, etc.)

          3. Nightshift workers.

          4. Participants who have a plan to travel beyond three time zones during the study.

          5. Participants with a history of, concurrent, or suspicious functional dyspepsia or
             functional heartburn based on Rome IV criteria.

          6. Participants with history of surgery or treatment affecting gastroesophageal reflux
             (fundoplication or dilation for esophageal stenosis [except for Schatzki's ring],
             etc.).

          7. 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.

          8. Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy.

          9. Participants who took antidepressant agents or anti-anxiety agents within 8 weeks
             before the time of informed consent.

         10. Participants who took H2 receptor antagonist within 8 weeks before the time of
             informed consent.

         11. Participants planning to take prohibited concomitant medications during the study
             period.

         12. Participants who have any of the following abnormal clinical laboratory test values at
             the screening (VISIT 1):

               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit
                  of normal (ULN)

               -  Bilirubin (Total bilirubin) > ULN

         13. Participants with a malignant tumor.

         14. Participants who are pregnant, breast-feeding, possibly pregnant, or planning to
             become pregnant.

         15. Participants who have serious renal diseases.

         16. Participants with the conditions listed under administration contraindication in the
             vonoprazan package insert.

         17. Participants participating in other clinical studies.

         18. Participants who have been determined as inappropriate participants by the
             investigator.