Vonoprazan vs Acotiamide for FD: Double-blind RCT

Efficacy of Vonoprazan versus Acotiamide in Patients with Functional Dyspepsia: A double-blind randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190175

Enrollment

Registered

2020-01-06

Start date

2020-01-06

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

Functional Dyspepsia FD

Interventions

(1)Vonoprazan: 5mg tid (15mg/day) 4 weeks (2)Acotiamide: 100mg tid (300mg/day) 4 weeks

Vonoprazan, Acotiamide

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients diagnosed with Functional Dyspepsia (FD) according to the Rome IV criteria. (2)Patients who give a written informed consent.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Elimination rate of all FD symptoms (postprandial fullness,upper abdominal bloating, early satiation and epigastric pain, epigastric burning) after 4 weeks intervention.	—

Secondary

Measure	Time frame
Improvement rate of overall treatment efficacy (OTE) after 4 weeks intervention.	—

Contacts

Public ContactSoichiro Sue

Yokohama City University Hospital

ssue@yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

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