Functional DyspepsiaPhase 4NCT04918017
Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients
A Phase 4 study testing Treatment based on subtypes: Esomeprazole or Itopride and Treatment with proton pump inhibitor regardless of subtype: Esomeprazole in people with Functional Dyspepsia, run by University of Malaya at 1 site in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Treatment based on subtypes: Esomeprazole or Itopride and Treatment with proton pump inhibitor regardless of subtype: Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Nov 2021to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur
Kee Huat Chuah, MBBS
About this study
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.
Read more
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
- Being tested
- Treatment based on subtypes: Esomeprazole or Itopride, Treatment with proton pump inhibitor regardless of subtype: Esomeprazole
- Keywords
- Itopride, Proton Pump Inhibitor, Functional dyspepsia, FGID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 with proton pump inhibitor regardless of subtype: EsomeprazoleDrug
Esomeprazole 40mg OD
| Study group | Role | What they receive |
|---|---|---|
| Treatment based on subtypes: Epigastric Pain Syndrome (EPS) | Experimental | EPS: treat with esomeprazole 40mg OD (proton pump inhibitor) Receives: 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) Receives: 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) Receives: 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 Receives: Drug: Treatment with proton pump inhibitor regardless of subtype: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
Individual upper gastrointestinal (UGI) symptoms change
Change in individual upper gastrointestinal (UGI) symptoms (total 9 symptoms). Patients will be assessed on nine UGI symptoms (upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, excessive belching, nausea, vomiting and heartburn) and they will rate each symptom on a severity scale of 0-3 (none, mild, moderate and severe).
On assessment of individual symptoms, patients who have a decrease in symptom severity of ≥50% from baseline are considered responders. Nine individual symptoms are evaluated and compared between intervention and routine practice group.
Measured: 8 weeks
Change of quality of life
The change in Health-Related Quality of Life (HRQOL) score based on Short Form-Napean Dyspepsia Index Questionnaire (SF-NDI).
It is a 10-item questionnaire with 5 sub-scales each examining the influence of dyspepsia on domains of health in patients, namely tension/anxiety, interference with daily activities, disruption to regular eating/drinking, knowledge towards/control over disease symptoms and interference with work/study, with each sub-scale containing two items [10]. Each item is measured by a 5-point Likert scale ranging from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely). Individual items in each sub-scale are aggregated to obtain a score range from 0 (lowest HRQoL score) to 100 (highest HRQoL score) as per the developers' original calculation formula. A total, overall SF-NDI total score is obtained using the mean of 5 subscale scores.
Measured: 8 weeks
Incidence of Adverse effects
Incidence of adverse events of treatment will be assessed.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start18 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chuah Kee Huat, University of Malaya
- Investigators
- Kee-Huat Chuah, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918017
- Sponsor's protocol ID
- 12345676
- Status last verified
- May 2023
- First submitted
- 4 May 2021
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39618195
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients
- ClinicalTrials.gov ID
- NCT04918017
- Acronym / sponsor ID
- 12345676
- Conditions
- Functional Dyspepsia
- Keywords
- Itopride, Proton Pump Inhibitor, Functional dyspepsia, FGID
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment based on subtypes: Epigastric Pain Syndrome (EPS) | Experimental | Drug: Treatment based on subtypes: Esomeprazole or ItoprideEPS: treat with esomeprazole 40mg OD (proton pump inhibitor) |
| Treatment based on subtypes: Post Prandial Distress Syndrome (PDS) | Experimental | Drug: Treatment based on subtypes: Esomeprazole or ItopridePDS: treat with itopride 50mg TDS (prokinetic) |
| Treatment based on subtypes: Overlapped EPS/ PDS | Experimental | Drug: Treatment based on subtypes: Esomeprazole or ItoprideOverlapped 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 with Proton Pump Inhibitor regardless of subtype | Active comparator | Drug: Treatment with proton pump inhibitor regardless of subtype: EsomeprazoleTreat with esomeprazole 40mg OD (proton pump inhibitor) regardless of subtype of functional dyspepsia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment based on subtypes: Esomeprazole or ItoprideEsomeprazole 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 based on subtypes: Epigastric Pain Syndrome (EPS), Treatment based on subtypes: Overlapped EPS/ PDS, Treatment based on subtypes: Post Prandial Distress Syndrome (PDS) |
| Treatment with proton pump inhibitor regardless of subtype: EsomeprazoleEsomeprazole 40mg OD | Drug | Treatment with Proton Pump Inhibitor regardless of subtype |
Primary outcome
Global symptom change in patients with FD when managed according to guidelines, compare to routine practice
Time frame: 8 weeks
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.
3 secondary outcomes
Individual upper gastrointestinal (UGI) symptoms change
Time frame: 8 weeks
Change of quality of life
Time frame: 8 weeks
Incidence of Adverse effects
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 39618195Chuah 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.
- Individual participant dataSharing planned: No
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Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kee-Huat Chuah principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment based on subtypes: Esomeprazole or Itopride and Treatment with proton pump inhibitor regardless of subtype: Esomeprazole in people with Functional Dyspepsia, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kee-Huat Chuah, MBBS (+60379492965, chuah319@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global symptom change in patients with FD when managed according to guidelines, compare to routine practice (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.