Medicinal treatment on symptoms in patients with gastroesophageal reflux disease (GERD) refractory to PPIs. Multicenter, randomized, paralleled controlled study

Medicinal treatment on symptoms in patients with gastroesophageal reflux disease (GERD) refractory to PPIs. Multicenter, randomized, paralleled controlled study - Medicinal treatment for patients with PPIs-refractory GERD patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003716

Enrollment

120

Registered

2010-06-07

Start date

2008-04-01

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

Gastroesophageal reflux disease (GERD)

Interventions

Oral administration of rabeprazole (10mg) combined with rikkunshito (7.5g) before meals for 28 days Oral administration of rabeprazole (20mg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) GERD patients who were received a treatment of rabeprazole (10 mg once daily) for more than 4 weeks. 2) Patients who were defined as a score of more than 8 points estimated using the frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) after treatment with rabeprazole at standard dose (10 mg, once daily). 3) Patients who are able to administer orally 4) Patients who have signed consent to participate in this research

Exclusion criteria

Exclusion criteria: 1) Patients with GERD which had C or D grade esophagitis diagnosed by endoscopic testing. 2) Patients with serious complications (e.g., hepatic, renal, cardiac, pulmonary, hematological, or metabolic diseases) 3) Patients with abscission of upper gastrointestinal tract 4) Patients who had peptic ulcer (excusing cicatrices) or tumor. 5) Patients with disorder in liver, gallbladder, or pancreas 6) Patients with gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation. 7) Patients who received drugs prohibited for concomitant use during the observation period 8) Patients who were received treatment of rabeprazole (20mg) 9) Patients with psychoneurosis 10) Patients with planning or during treatment of investigational drug 11) Patients with pregnant, considering pregnancy or lactation 12) Patients considered inappropriate by the study investigator

Design outcomes

Primary

Measure	Time frame
Evaluation of acid reflux-related symptoms using Frequency scale for symptoms of GERD (FSSG)	—

Secondary

Measure	Time frame
Subgroup analysis for age, gender, BMI or endoscopic diagnose	—

Countries

Japan

Contacts

Public ContactFujimoto Kazuma

Saga University Hospital Department of Internal Medicine

0952-34-2361

Outcome results

None listed

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