Risk factors for recurrence after initial treatment with vonoprazan 20 mg/day in patients with mild reflux esophagitis: A prospective multicenter study

Risk factors for recurrence after initial treatment with vonoprazan 20 mg/day in patients with mild reflux esophagitis: A prospective multicenter study - Risk factors for recurrence after initial treatment with vonoprazan 20 mg/day in patients with mild reflux esophagitis: A prospective multicenter study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055462

Enrollment

150

Registered

2024-09-11

Start date

2024-09-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux disease (mild)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects are adult patients who have been diagnosed with mild reflux esophagitis (Los Angeles Classification Grade A or B) by endoscopy before starting vonoprazan, and who have shown symptomatic cure by initial administration of 20 mg/day vonoprazan for 4 weeks, or for an additional 8 weeks if symptoms persist, following health insurance medical care in Japan. The therapeutic effect will be assessed using the GerdQ questionnaire, and symptoms will be cured if the score for questions 1, 2, 5, and 6 is 1 or less.

Exclusion criteria

Exclusion criteria: Patients with any of the following conditions will be excluded. 1) Severe reflux esophagitis 2) Non-erosive reflux esophagitis 3) Gastroduodenal ulcer 4) Post-surgery of the upper gastrointestinal tract 5) Use of acid secretion inhibitors (H2 blockers, PPIs, P-CABs) within the past 3 months 6) Use of medications that affect reflux esophagitis or heartburn (analgesics such as Rikkunshito, mosapride citrate, acotiamide, antipsychotics, and NSAIDs) 7) Severe systemic disease 8) Psychiatric disease

Design outcomes

Primary

Measure	Time frame
Factors associated with symptom recurrence 2 weeks after discontinuing vonoprazan	—

Secondary

Measure	Time frame
Factors associated with symptom recurrence 4 weeks after discontinuation of vonoprazan Factors associated with symptom recurrence 2 or 4 weeks after discontinuation of vonoprazan	—

Countries

Japan

Contacts

Public ContactKenta Watanabe

Akita University Graduate School of Medicine Department of Gastroenterology

nabeken@med.akita-u.ac.jp018-884-6104

Outcome results