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Study on medical treatment for patients with reflux esophagitis refractory to proton pump inhibitor

Study on medical treatment for patients with reflux esophagitis refractory to proton pump inhibitor - Treatment for patients with reflux esophagitis refractory to proton pump inhibitor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003911
Enrollment
50
Registered
2010-07-20
Start date
2010-08-01
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

Oral administration of omeprazole (20mg) for 56 days

Sponsors

Department of Gastroenterology, Kobe University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who have gave a written consent to participate in this study (2) Patients who were diagnosed as having erosive reflux esophagitis previously (3) Patients who are receiving rabeprazole 10mg per day for more than 8 weeks (4) Patients whose score of Frequency scale for symptoms of gastroesophageal reflux diseases (FSSG) are 8 or more points

Exclusion criteria

Exclusion criteria: (1) Patients with the past history of digestive tract excisio and vagotomy (2) Patients who have alert symptoms such as nausea, gastrointestinal bleeding and rapid weight loss (3) Patients who have past history of or suffer from the following diseases: Zollinger-Ellison symdrome, inflammatory bowel disease, esophageal stenosis, achalasia, malabsorption, cerebrovascular disease such as cerebral hemorrhage or cerebral infarction (4) Patients having severe liver, kidney or heart disease (5) Patients who have malignancy or are suspected of having malignancy (6) Patients who are pregnant, in breast-feeding or may have cecome pregnant (7) Patients who need continuous medication of atazanavir sulfate, diazepam, phenytoin, warfarin, tacrolimus, digoxin, methyldigoxin, itraconazole, Gefinitinib or voriconazole that might interact with the test drug (8) Patients who are receiving proton pump inhibitors except rabeprazole (9) Patients whom the doctor in charge judged to be unsuitable as an object of this study

Design outcomes

Primary

MeasureTime frame
Changes in scores of Frequency scale for symptoms of gastroesophageal reflux diseases (FSSG)

Secondary

MeasureTime frame
1)Changes in scores of gastrointestinal symptom rating scale (GSRS) 2)Subgroup analysis for CYP2C19 genotype

Countries

Japan

Outcome results

None listed

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