NCT04918017

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Treatment based on subtypes: Esomeprazole or Itopride	Esomeprazole 40mg OD for EPS and Itopride 50mg TDS for PDS In overlapped EPS/ PDS: treat with Itopride 50mg TDS first and then add Esomeprazole 40mg OD (if partially responded- assessed at week 4) or treat with Itopride 50mg TDS first and then change to Esomeprazole 40mg OD (if not responded- assessed at week 4)
DRUG	Treatment with proton pump inhibitor regardless of subtype: Esomeprazole	Esomeprazole 40mg OD

Timeline

• Start date: 2021-11-18
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-06-08
• Last updated: 2023-05-16

Locations

1 site across 1 country: Malaysia