Multicenter prospective randomized controlled trial of Vonoprazan and Esomeprazole for reflux esophagitis

Phase 4

Recruiting

• Conditions: Reflux esophagitis; GERD; K210

• Registration Number: JPRN-jRCTs031200417
• Lead Sponsor: Matsumura Tomoaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients who meet all of the following criteria will
be included:
1) Patients with reflux esophagitis: patients with erosive esophagitis of Los Angeles classification grade A-D with endoscopic examination.
2) Patients with hearburn symptoms
3) Age of 20 years or older (any gender).
4) Patients who have been fully informed of and have obtained written consent of their own free will
to participate in the study

Exclusion Criteria

Applicants who meet any of the following conditions are not eligible
1) Highly obese patients with a body mass index (BMI) of 35 or higher
2) Patients with hiatus hernia (3cm or more)
3) Patients taking other antacids, including PPIs (e.g. histamine H2 receptor antagonists) within 14 days prior to obtaining consent
4) Patients who have taken regular NSAIDs, including glucocorticosteroids and COX-2 inhibitors, on at least 3 consecutive days per week within the past 28 days; exception: regular intake of up to 150 mg/day of acetylsalicylic acid.
5) Patients with a history of esophageal, gastric or duodenal surgery.
6) Patients with esophageal stenosis
7) Patients with scleroderma
8) Patients who may have an allergic reaction to the study drug
9) Patients with substance abuse or health, psychological, or social conditions that interfere with participation in the study and the evaluation of results
10) Pregnant women, lactating women, and patients who may or will become pregnant (a pregnancy test should be performed if pregnancy is suspected)
11) Patients who are deemed unsuitable for inclusion by the principal investigator or sub-physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom recurrence rate up to 12 weeks after completion of 8 weeks of Esomeprazole or 8 weeks of Vonoprazan treatment

Secondary Outcome Measures

Name	Time	Method
Symptom recurrence rate up to 12 weeks after completion of 8 weeks of Esomeprazole or 4 weeks of Vonoprazan treatment<br>Symptom recurrence rate up to 12 weeks after completion of treatment with Vonoprazan 4 weeks or Vonoprazan 8 weeks<br>The rate of disappearance of symptoms at the end of the initial treatment<br>Endoscopic cure rate at the end of initial treatment (percentage of patients with cured erosive esophagitis)<br>Duration of time until symptoms disappear(number of days until symptoms disappear for 7 days)<br>Progression-free period during follow-up <br>Total dosage during follow-up (total dosage of Vonoprazan and Esomeprazole during the entire observation period)<br>Medical expenses spent during the entire observation period (from initial treatment to the end of the study)