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

NCT ID: NCT04918017

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment based on subtypes: Epigastric Pain Syndrome (EPS)

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

Group Type: EXPERIMENTAL

Treatment based on subtypes: Esomeprazole or Itopride

Intervention Type: DRUG

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)

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

PDS: treat with itopride 50mg TDS (prokinetic)

Group Type: EXPERIMENTAL

Treatment based on subtypes: Esomeprazole or Itopride

Intervention Type: DRUG

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)

Treatment based on subtypes: Overlapped EPS/ PDS

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)

Group Type: EXPERIMENTAL

Treatment based on subtypes: Esomeprazole or Itopride

Intervention Type: DRUG

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)

Treatment with Proton Pump Inhibitor regardless of subtype

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

Group Type: ACTIVE_COMPARATOR

Treatment with proton pump inhibitor regardless of subtype: Esomeprazole

Intervention Type: DRUG

Esomeprazole 40mg OD

Interventions

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)

Intervention Type: DRUG

Treatment with proton pump inhibitor regardless of subtype: Esomeprazole

Esomeprazole 40mg OD

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Dr. Chuah Kee Huat

Principal Investigator, Clinical Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kee-Huat Chuah

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Kee-Huat Chuah, MBBS

Role: CONTACT

chuah319@yahoo.com

+60379492965

Facility Contacts

Kee Huat Chuah, MBBS

Role: primary

References

Chuah KH, Loo QY, Hian WX, Khoo XH, Panirsheeluam S, Jubri NBM, Natarajan V, Khoo S, Mahadeva S. Clinical Trial: Treatment of Functional Dyspepsia According to Subtype Compared With Empirical Proton Pump Inhibitor. Aliment Pharmacol Ther. 2025 Jan;61(2):258-267. doi: 10.1111/apt.18418. Epub 2024 Dec 2.

Reference Type: DERIVED

PMID: 39618195 (View on PubMed)

Other Identifiers

12345676

Identifier Type: -

Identifier Source: org_study_id