Investigation of symptomatic change after withdrawal in patients with reflux esophagitis

JRCT ID: jRCTs051180209

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: reflux esophagitis
• Date of first enrollment: 21/08/2018
• Target sample size: 150
• Study type: Interventional
• Intervention(s): For blood gastrin, blood H. pylori antibody, blood pepsinogen measurement, 3 ml of blood is collected from subjects registered before drug withdrawal. In addition, ask the subjects to fill out GSRS, FSSG, HADS questionnaire as symptom questionnaire. Collect the symptom questionnaire brought by the subject at the visit 4 weeks later and collect blood of 3 ml each for gastrin measurement. The blood test at the time of registration and 4 weeks after the visit is collected and measured from each research institution by the inspection and measurement institution SRL Co., Ltd. The measurement result is reported to each research institution, and the research sharing physician records the result of the blood test on the questionnaire / case report. Study sharing physician mails questionnaire / case report and symptom questionnaire (GSRS, FSSG, HADS) to research researcher. The researcher will anonymize the questionnaire / case report and the symptom questionnaire and mail it to the secretariat, MC and P Co. Ltd.

Outcome(s)

• Primary Outcome: Investigate the correlation between FSSG total score change and H. pylori infection, pepsinogen I / II ratio, bloody gastrin value, sex, age, BMI, smoking, esophageal hiatal hernia.

Secondary Outcome

(1)Number of days to symptom onset. (symptoms diary)
(2)Investigate factors on affecting GSRS score including subscale, FSSG (reflux, motility) score, and HADS (depression) score value of change exploratory.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Reflux esophagitis of LA grade A or B.
(2) Patients undergoing treatment for more than 1 month at maintenance therapy for reflux esophagitis of Acid inhibitors (H2 receptor antagonist, proton pump inhibitor, potassium competitive acid blocker).
(3) Patient with FSSG total score less than 8 points.

Exclude criteria

(1) Refractory reflux esophagitis which resistant treatment for more than 4 weeks with PPI or P-cab
(2) Patients with peptic ulcer
(3) Patients in need of treatment due to functional dyspepsia, irritable bowel syndrome, inflammatory bowel disease complicated.
(4) Patients with Zollinger-Ellison syndrome, advanced atrophic gastritis (Kimura Takemoto classification: O3) or malignant anemia.
(5) Patients with a history of upper gastrointestinal resection or vagotomy.
(6) At the time of registration H2 receptor antagonists, gastrointestinal motility improving drugs (including Rokkunshito), anticholinergic drugs, antidepressants, anxiolytics, steroids (excluding external preparations), nonsteroidal anti-inflammatory analgesics (NSAIDs) , Aspirin preparations containing low-dose aspirin, bisphosphonate preparations, patients taking calcium antagonists.

Related Information

• Primary Sponsor: Higuchi Kazuhide
• Source(s) of Monetary Support: AstraZeneca K.K.
• Secondary ID(s): UMIN000029957