Status:
UNKNOWN
Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients
Lead Sponsor:
University of Malaya
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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) a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04918017
Start Date
November 18 2021
End Date
December 31 2023
Last Update
May 16 2023
Active Locations (1)
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1
University Malaya Medical Centre
Kuala Lumpur, Malaysia