Clinical trial NCT04918017: Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients
Official title: Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Functional Dyspepsia
Keywords: Itopride
Proton Pump Inhibitor
Functional dyspepsia
FGID
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Global symptom change in patients with FD when managed according to guidelines, compare to routine practice
timeFrame: 8 weeks
Secondary outcomes:
measure: Individual upper gastrointestinal (UGI) symptoms change
timeFrame: 8 weeks
measure: Change of quality of life
timeFrame: 8 weeks
measure: Incidence of Adverse effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
Study officials:
affiliation: University of Malaya
name: Kee-Huat Chuah
role: PRINCIPAL_INVESTIGATOR
References: