To evaluate treatment efficacy after switching medication in reflux esophagitis patients who have parsistent gastro- esophageal reflux symptoms despite standard PPI therapy

To evaluate treatment efficacy after switching medication in reflux esophagitis patients who have parsistent gastro- esophageal reflux symptoms despite standard PPI therapy - To evaluate treatment efficacy after switching medication in PPI refractory GERD patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009398

Enrollment

Registered

2012-12-01

Start date

2012-12-01

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

Gastroesophageal reflux disease

Interventions

Baseleine 24-hr pH/MII monitoring 20mg-esomeprazole

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) The patient provides written voluntary consent to participate in the study after sufficient written and oral explanations. (2) The patient is a man or woman aged 20 years or older. (3) The patient has refractory reflux esophagitis and has been on the standard dose of an existing PPI (omeprazole 20 mg, lansoprazole 30 mg, or rabeprazole 10 mg) for at least 8 weeks prior to screening. (4) The patient does not sufficiently respond to the treatment as confirmed by the Treatment Response, GerdQ questionnaire.

Exclusion criteria

Exclusion criteria: (1) The patient has warning signs such as vomiting and gastrointestinal hemorrhage. (2) The patient needs to continue any drug that might interact with esomeprazole. (3) The patient previously had or currently has any of the following diseases. Zollinger-Ellison syndrome Esophageal stenosis Esophageal achalasia Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction (4) The patient has any serious hepatic, renal, or cardiac disease that makes participation in the study difficult in the opinion of the investigator. (5) The patient has a confirmed or suspected malignant lesion. (6) The patient is a pregnant, nursing, or possibly pregnant woman. (7) The patient is otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion.

Design outcomes

Primary

Measure	Time frame
Change in the FSSG score at Week 2 of esomeprazole treatment	—

Secondary

Measure	Time frame
1. Change in the FSSG score at Week 2 of esomeprazole treatment by pathological factor revealed through baseline 24-hr pH/MII monitoring (the change in the FSSG score will be evaluated for each of the following pathological factors) I. SI positive or negative II. Presence or absence of pathological acid reflux 2. Percentage of subjects with insufficient treatment response as confirmed by the GerdQ at Week 2 Percentage of subjects with gastroesophageal reflux symptoms at least 1 day per week at Week 2 3. Patient background factors that affect the change rate of the FSSG score after starting esomeprazole treatment	—

Measure

Time frame

1. Change in the FSSG score at Week 2 of esomeprazole treatment by pathological factor revealed through baseline 24-hr pH/MII monitoring (the change in the FSSG score will be evaluated for each of the following pathological factors) I. SI positive or negative II. Presence or absence of pathological acid reflux 2. Percentage of subjects with insufficient treatment response as confirmed by the GerdQ at Week 2 Percentage of subjects with gastroesophageal reflux symptoms at least 1 day per week at Week 2 3. Patient background factors that affect the change rate of the FSSG score after starting esomeprazole treatment

—

Countries

Japan

Contacts

Public ContactFumiaki Yano

The Jikei University School of Medicine Department of Surgery

f-yano@jikei.ac.jp03-3433-1111

Outcome results

None listed

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