Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- University of Malaya
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Global symptom change in patients with FD when managed according to guidelines, compare to routine practice
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change of quality of life(8 weeks)
- Incidence of Adverse effects(12 weeks)
- Individual upper gastrointestinal (UGI) symptoms change(8 weeks)
Investigators
Dr. Chuah Kee Huat
Principal Investigator, Clinical Specialist
University of Malaya