Comparative Efficacy and Safety of Acotiamide versus Domperidone in the Treatment of Functional Dyspepsia: A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250319014

Enrollment

160

Registered

2025-03-19

Start date

2025-04-21

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia patient Functional dyspepsia Post prandial distress syndrome Acotiamide Domperidone GOSS score

Interventions

1) Informing consent: Explain the details of the research and request written consent. 2) Basic data collection: Collect demographic data, medical history, medications used, and history of drug allerg

s previous blood and ECG results within the past 6 months). 5) Randomly divide patients into the acothiamide group. A computer program was used to randomize the patients. Each patient will receive an

Experimental Drug,Active Comparator Drug

Acotiamide,Domperidone

Eligibility

Sex/Gender

All

Age

20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 20-65 Years 2. Diagnosed with irritable bowel syndrome (FD-PDS) based on Rome IV diagnostic criteria and with persistent symptoms for at least 3 months within the past 6 months. 3. Have undergone an esophagogastroduodenoscopy (EGD) within the past 3 years and no abnormalities in the esophagus, duodenum, or stomach were found.

Exclusion criteria

Exclusion criteria: 1. Gastrointestinal diseases due to anatomical abnormalities (e.g. stomach and small intestine ulcers, cancer) 2. History of allergy to acothimide or domperidone 3. Being treated for Helicobacter pylori infection 4. Have heart disease, arrhythmias, or QT prolongation on electrocardiography 5. Have liver failure, kidney failure, cancer 6. Pregnancy, breastfeeding, or planning to become pregnant 7. Psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Overall Treatment Effect and percentage of day without symptoms) 4 weeks Global Overall Symptom scale (GOSS) and Short-Form Nepean Dyspepsia Index (SF-NDI) score	—

Secondary

Measure	Time frame
Changing Score and Safety 4 weeks Global Overall Symptom scale (GOSS), Short-Form Nepean Dyspepsia Index (SF-NDI) score and adveres event	—

Countries

Thailand

Contacts

Public ContactWasinee Kaewboot

Faculty of Medicine, Chiang Mai University

jeapjjeap@gmail.com053936120

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026