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

JRCT ID: jRCTs031200417

Registered date:12/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Reflux esophagitis
• Date of first enrollment: 30/09/2021
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Vonoprazan/Esomeprazole

Outcome(s)

• Primary Outcome: Symptom recurrence rate up to 12 weeks after completion of 8 weeks of Esomeprazole or 8 weeks of Vonoprazan treatment

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Matsumura Tomoaki
• Source(s) of Monetary Support: Chiba University Hospital