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A randomized controlled trial comparing PCAB and PPI therapy for Los Angeles classification Grade C/D reflux esophagitis patient

A randomized controlled trial comparing PCAB and PPI therapy for Los Angeles classification Grade C/D reflux esophagitis patient - RCT comparing PCAB and PPI for reflux esophagitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031633
Enrollment
160
Registered
2018-03-09
Start date
2017-04-01
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

Reflux esophagitis

Interventions

PCAB: Vonoprazan 20mg/day 8 weeks PPI: Rabeprazole 10mg/day 8 weeks or Esomeprazole 20mg/day 8 weeks

Sponsors

Yokohama City University (Basic research expenditures)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)A patient who was endoscopically diagnosed as Los Angeles classification Grade C/D severe reflux esophagitis. (2)A patient who have treatment history of PPI or PCAB. (3)A patient who is ambulatory and who can answer the questionnaire. (4)A patient who give a written informed consent.

Exclusion criteria

Exclusion criteria: (1)A patient with history of gastrectomy which may cause regurgitation of bile acid or pancreatic juice. (2)A patient who use PPI or H2RA already. (3)A patient with pregnancy. (4)A patient with lactation. (5)Past history of allergy for the drug used in this study. (6)Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. (7)A patient who is disqualified for the study by physicians.

Design outcomes

Primary

MeasureTime frame
Endoscopic cure rate :a rate becoming Las Angeles classification grade M or N.

Secondary

MeasureTime frame
Subjective symptoms disappearance rate :Using questionnaire for GERD symptom: Frequency Scale for the Symptoms of GERD (FSSG, F-scale), the rate is defined as (pre F-scale score - post F-scale score)/(pre F-scale score)*100. F-scale of pre and post 4 weeks and 8 weeks is used.

Countries

Japan

Contacts

Public ContactToshihide Tamura

Yokohama City University Hospital Gastroenterology

Tamura.Toshihide@gmail.com045-787-2326

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026