Vonoprazan vs Acotiamide for FD: Double-blind RCT

JRCT ID: jRCTs031190175

Registered date:06/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Functional Dyspepsia
• Date of first enrollment: 06/01/2020
• Target sample size: 80
• Study type: Interventional

Intervention(s)

(1)Vonoprazan: 5mg tid (15mg/day) 4 weeks

(2)Acotiamide: 100mg tid (300mg/day) 4 weeks

Outcome(s)

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

Key inclusion & exclusion criteria

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

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

• Primary Sponsor: Sue Soichiro
• Source(s) of Monetary Support: Yokohama City University