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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031190175

Registered date:06/01/2020

Vonoprazan vs Acotiamide for FD: Double-blind RCT

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedFunctional Dyspepsia
Date of first enrollment06/01/2020
Target sample size80
Countries of recruitment
Study typeInterventional
Intervention(s)(1)Vonoprazan: 5mg tid (15mg/day) 4 weeks (2)Acotiamide: 100mg tid (300mg/day) 4 weeks

Outcome(s)

Primary OutcomeElimination rate of all FD symptoms (postprandial fullness,upper abdominal bloating, early satiation and epigastric pain, epigastric burning) after 4 weeks intervention.
Secondary OutcomeImprovement rate of overall treatment efficacy (OTE) after 4 weeks intervention.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria(1)Patients diagnosed with Functional Dyspepsia (FD) according to the Rome IV criteria. (2)Patients who give a written informed consent.
Exclude criteria(1)Patients allergic to vonoprazan or acotiamide. (2)Current administration of atazanavir sulfate or rilpivirine. (3)Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. (4)Pregnancy. (5)Current infection of Helicobacter pylori with gastritis. Past history of Helicobacter pylori (patients successfully eradicated) does not meet exclusion criteria and can be included to this study. Non-Erosive Reflux Disease (NERD), Irritable bowel syndrome (IBS), and atrophic gastritis does not meet exclusion criteria and can be included to this study. (6)Administration of following drugs within the past four weeks: proton pump inhibitors (esomeprazole, rabeprazole, lansoprazole, and omeprazole), histamine-type 2 receptor blocker (famotidine, ranitidine, cimetidine, nizatidine, roxatidine, and lafutidine), selective serotonin 5-HT4 agonist (mosaprid citrate), opiate agonist (trimebutine maleate), dopamine receptor antagonist (metoclopramide, domperidone), acetylcholine agonist (SM combination powder), Tsumura-Kampo Rikkunshito, Tsumura-Kampo Anchusan, Tsumura-Kampo Hangekobokuto, atropine, butylscopolamine, acetylcholine chloride, and neostigmine bromide. (7)Patients who is disqualified for the study by physicians.

Related Information

Contact

Public contact
Name Soichiro Sue
Address 3-9, Fukuura, Kanazawa, Yokohama, Kanagawa Kanagawa Japan 236-0004
Telephone +81-45-787-2800
E-mail ssue@yokohama-cu.ac.jp
Affiliation Yokohama City University Hospital
Scientific contact
Name Soichiro Sue
Address 3-9, Fukuura, Kanazawa, Yokohama, Kanagawa Kanagawa Japan 236-0004
Telephone +81-45-787-2800
E-mail ssue@yokohama-cu.ac.jp
Affiliation Yokohama City University Hospital