NCT04918017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 18, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

May 4, 2021

Last Update Submit

May 14, 2023

Conditions

Functional Dyspepsia

Keywords

ItoprideProton Pump InhibitorFunctional dyspepsiaFGID

Outcome Measures

Primary Outcomes (1)

  • Global symptom change in patients with FD when managed according to guidelines, compare to routine practice

    Assessment of global symptom change using 'Overall Treatment Effect' (OTE) questionnaire from baseline to 8 weeks of treatment. Patients who were 'extremely improved' or 'improved' on the OTE scale are considered responders. This will be compared with intervention arm and routine practice arm.

    8 weeks

Secondary Outcomes (3)

  • Individual upper gastrointestinal (UGI) symptoms change

    8 weeks

  • Change of quality of life

    8 weeks

  • Incidence of Adverse effects

    12 weeks

Study Arms (4)

Treatment based on subtypes: Epigastric Pain Syndrome (EPS)

EXPERIMENTAL

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

Drug: Treatment based on subtypes: Esomeprazole or Itopride

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

EXPERIMENTAL

PDS: treat with itopride 50mg TDS (prokinetic)

Drug: Treatment based on subtypes: Esomeprazole or Itopride

Treatment based on subtypes: Overlapped EPS/ PDS

EXPERIMENTAL

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)

Drug: Treatment based on subtypes: Esomeprazole or Itopride

Treatment with Proton Pump Inhibitor regardless of subtype

ACTIVE COMPARATOR

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

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

Interventions

Treatment based on subtypes: Esomeprazole or ItoprideDRUG

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: Epigastric Pain Syndrome (EPS)Treatment based on subtypes: Overlapped EPS/ PDSTreatment based on subtypes: Post Prandial Distress Syndrome (PDS)
Treatment with proton pump inhibitor regardless of subtype: EsomeprazoleDRUG

Esomeprazole 40mg OD

Treatment with Proton Pump Inhibitor regardless of subtype

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with known hypersensitivity to Itopride and/or proton pump inhibitors or to any of the excipients of the study medication
  • Patients with a contraindication to any of the study drugs
  • Pregnant / breast feeding women
  • 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
  • Patients consuming regular Aspirin or NSAIDs (except low-dose Aspirin at a dose of 325 mg/day or less for cardiovascular prophylaxis)
  • History of erosive esophagitis, peptic ulcer disease within 1 year prior to the screening
  • History of gastrointestinal (GI) malignancy, primary esophageal motility disorder, documented upper GI surgery
  • Patients with any hepatobiliary or pancreatic diseases
  • Patients with severe depression, anxiety, or other psychological disorder
  • Patients with any terminal disease
  • Presence of irritable bowel syndrome (Rome IV criteria) or inflammatory bowel disease (IBD)
  • Other conditions determined by the investigator to be inappropriate for this clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Malaysia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39618195DERIVED

MeSH Terms

Interventions

itoprideTherapeutics

Study Officials

  • Kee-Huat Chuah

    University of Malaya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kee-Huat Chuah, MBBS

CONTACT

+60379492965chuah319@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Specialist

Study Record Dates

First Submitted

May 4, 2021

First Posted

June 8, 2021

Study Start

November 18, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)