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

University of Malaya

Status and phase: Enrolling; Phase 4

Conditions: Functional Dyspepsia

Treatments: Drug: Treatment with proton pump inhibitor regardless of subtype: Esomeprazole; Drug: Treatment based on subtypes: Esomeprazole or Itopride

Study type: Interventional

Funder types: Other

Identifiers

NCT04918017

12345676

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with Functional Dyspepsia using Rome IV diagnostic criteria: patients on prior dyspepsia treatment can be recruited after washout period of 2 weeks
2. Subject who has ability to provide written informed consent and willingness to comply with the requirement of the protocol
3. Able to communicate in English, Malay or Mandarin languages

Exclusion criteria

1. Patients with known hypersensitivity to Itopride and/or proton pump inhibitors or to any of the excipients of the study medication
2. Patients with a contraindication to any of the study drugs
3. Pregnant / breast feeding women
4. Presence of family history of GI malignancy or alarm features suggested malignancy - e.g. Unintentional weight loss (≥ 10% of body weight in recent 6 months), GI bleeding
5. Patients consuming regular Aspirin or NSAIDs (except low-dose Aspirin at a dose of 325 mg/day or less for cardiovascular prophylaxis)
6. History of erosive esophagitis, peptic ulcer disease within 1 year prior to the screening
7. History of gastrointestinal (GI) malignancy, primary esophageal motility disorder, documented upper GI surgery
8. Patients with any hepatobiliary or pancreatic diseases
9. Patients with severe depression, anxiety, or other psychological disorder
10. Patients with any terminal disease
11. Presence of irritable bowel syndrome (Rome IV criteria) or inflammatory bowel disease (IBD)
12. Other conditions determined by the investigator to be inappropriate for this clinical study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 4 patient groups

Treatment based on subtypes: Epigastric Pain Syndrome (EPS)

Experimental group

Description:

EPS: treat with esomeprazole 40mg OD (proton pump inhibitor)

Treatment:

Drug: Treatment based on subtypes: Esomeprazole or Itopride

Treatment based on subtypes: Post Prandial Distress Syndrome (PDS)

Experimental group

Description:

PDS: treat with itopride 50mg TDS (prokinetic)

Treatment:

Drug: Treatment based on subtypes: Esomeprazole or Itopride

Treatment based on subtypes: Overlapped EPS/ PDS

Experimental group

Description:

Overlapped EPS/PDS: treat with itopride 50mg TDS first and add esomeprazole 40mg OD (if partially responded) or change to esomeprazole 40mg OD (if not responded)

Treatment:

Drug: Treatment based on subtypes: Esomeprazole or Itopride

Treatment with Proton Pump Inhibitor regardless of subtype

Active Comparator group

Description:

Treat with esomeprazole 40mg OD (proton pump inhibitor) regardless of subtype of functional dyspepsia

Treatment:

Drug: Treatment with proton pump inhibitor regardless of subtype: Esomeprazole