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

NCT04918017 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-05-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Kee-Huat Chuah · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04918017 on ClinicalTrials.gov