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Study on treatment options for patients with reflux esophagitis who are refractory to proton pump inhibitor administration.

Study on treatment options for patients with reflux esophagitis who are refractory to proton pump inhibitor administration. - Study on treatment for patients with refractory reflux esophagitis with proton pump inhibitors.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003357
Enrollment
60
Registered
2010-04-01
Start date
2010-04-01
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

Changing of proton pump inhibitor from ransoprazole to omeprazole.

Sponsors

Department of Gastroenterology and Hepatology, Kansai Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who can give a written consent to the entry of the study. (2) Patients of 20 years old and over without distinction of gender. (3) Patients who were diagnosed as having reflux esophagitis (Grade M to D). (4) Patients who are taking ransoprazole 15mg or 30mg per day for more than 2 months. (5) Patients whose symptoms are more than 8 points by F scale evaluation.

Exclusion criteria

Exclusion criteria: (1) Patients who are under 20 years of age. (2) Patients who are allergic to the ingredient of the test drugs. (3) Patients who underwent an operation of intestinal resection or vagotomy. (4) Patients who have alert symptoms such as nausea, gastrointestinal bleeding and rapid body weight loss. (5). Patients who had previous medical history of or suffer from the following diseases:Zollinger-Ellison syndrome, inflammatory bowel disease, irritable bowel disease, esophageal stenosis, esophageal achalasia, malabsorption, cerebrovascular disease such as cerebral hemorrhage, cerebral infarction. (6) Patient who can not participate the study due to the coexistence of the diseases such as severe liver, renal or heart diseases. (7) Patients who have malignancy or suspected malignancy (Cured patients are eligible). (8) Patients who are pregnant, in breast-feeding, or may be pregnant. (9) Patients who need continuous medication with drugs that are contraindication or dangerous to the combination with the test drug. (10) Patients who take proton pump inhibitors except ransoprazole. (11) Patients who take drugs that may affect the evaluation of the test drug (Patients who take such drugs without changing the usage or doses during the study period are eligible). (12) Patients who are not considered to be eligible for the study by the doctor's judgment.

Design outcomes

Primary

MeasureTime frame
Treatment effect of omeprazole for patients with reflux esophagitis who are refractory to treatment with ransoprazole.

Countries

Japan

Contacts

Public ContactAkiyoshi Nishio

Department of Gastroenterology and Hepatology Takii Hospital, Kansai Medical University

06-6992-1001

Outcome results

None listed

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