NCT04918017

Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients

Status unknown Phase 4 Last updated 16 May 2023

What this trial tests

Phase 4 trial testing Treatment based on subtypes: Esomeprazole or Itopride in Functional Dyspepsia in 180 participants. Status unknown.

Timeline

18 November 2021

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	University of Malaya
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	180
Start date	18 November 2021
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Malaysia

Drugs / interventions tested

• Treatment based on subtypes: Esomeprazole or Itopride — full drug profile →
• Treatment with proton pump inhibitor regardless of subtype: Esomeprazole — full drug profile →

Conditions studied

• Functional Dyspepsia — all drugs for Functional Dyspepsia →

Sponsor

University of Malaya

Who can join

Adults 18 to 80, any sex, with Functional Dyspepsia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Functional dyspepsia (FD) is among the most established and common functional gastrointestinal disorders (FGIDs). FD is subdivided into two subtypes based on symptoms: epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS).

Based on international guidelines (Asian Consensus and Rome Consensus), a prokinetic, medication which promotes gut movement (such as Itopride) should be the 1st line treatment for the PDS sub-type and a proton pump inhibitor, medication which reduces stomach acid production (such as Esomeprazole) should be the 1st line treatment for the EPS sub-type.

However, in the routine practice in Malaysia, proton pump inhibitor is still commonly used as 1st line treatment for FD, regardless of subtypes. This may be one of the reasons why FD continues to be inadequately treated locally and causes poor health-related quality of life (QOL) in FD patients.

The purpose of this study is to compare the clinical symptoms and quality of life improvement in patients with functional dyspepsia (FD) after treatment according to international guidelines versus treatment according to routine practice. Adverse effects when managed according to guidelines versus routine practice will also be evaluated.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Trial: Treatment of Functional Dyspepsia According to Subtype Compared With Empirical Proton Pump Inhibitor.
   Chuah KH, Loo QY, Hian WX, Khoo XH, et al · · 2025 · cited 6× · PMID 39618195 · DOI 10.1111/apt.18418