The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole

NCT04720781 | Completed DMC

• 1 other identifier: Revisiting
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

After vonoprazan (20mg/day) or esomeprazole (20mg/day) for 4weeks is prescribed for patients with erosive esophagitis diagnosed by esophagogastroduodenoscopy, the number of patients who will visit our outpatient clinic again due to some reasons without any appointments is compared with vonoprazan group and esomeprazole.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• The number of patients who revisit our outpatient clinic after the prescription without any appointments

  The need to revisit our outpatient clinic again without any appointments may show the patients' satisfaction or dissatisfaction after the prescription of vonoprazan or esomeprazole. The difference in the number between the two groups may show the difference in the effectiveness between the two medicines.

  3 months

Secondary Outcomes (1)

• Change of the main symptom with patients after/before medication when the patients revisit again

  3 months

Other Outcomes (1)

• Questionnaire on satisfaction with taking the medicine at revisiting

  3months

Study Arms (2)

Vonoprazan

ACTIVE COMPARATOR

Vonoprazan (20mg/day) is prescribed for patients with erosive esophagitis

Drug: Vonoprazan

Esomeprazole

PLACEBO COMPARATOR

Esomeprazole (20mg/day) is prescribed for patients with erosive esophagitis

Drug: Esomeprazole

Interventions

Vonoprazan DRUG

Vonoprazan (20mg/day) is prescribed for 4 weeks.

Also known as: Esomeprazole

Vonoprazan

Esomeprazole DRUG

esomeprazole (20mg/day)

Esomeprazole

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatients belonging to American Society of Anesthesiologists class I or II
• patients have erosive esophagitis diagnosed by esophagogastroduodenoscopy shortly before the prescription

You may not qualify if:

• other acid blockers are taken

Sponsors & Collaborators

• Showa Inan General Hospital: lead

Study Sites (1)

Showa Inan General hospital

Komagane, Nagano, 399-4191, Japan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Digestive Disease Center

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 22, 2021
• Study Start: January 21, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)