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Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients

Primary Purpose

Functional Dyspepsia

Status
Recruiting
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Treatment based on subtypes: Esomeprazole or Itopride
Treatment with proton pump inhibitor regardless of subtype: Esomeprazole
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Itopride, Proton Pump Inhibitor, Functional dyspepsia, FGID

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Malaya Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Treatment based on subtypes: Epigastric Pain Syndrome (EPS)

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

Treatment based on subtypes: Overlapped EPS/ PDS

Treatment with Proton Pump Inhibitor regardless of subtype

Arm Description

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

PDS: treat with itopride 50mg TDS (prokinetic)

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Incidence of Adverse effects
Incidence of adverse events of treatment will be assessed.

Full Information

First Posted
May 4, 2021
Last Updated
May 14, 2023
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT04918017
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Itopride, Proton Pump Inhibitor, Functional dyspepsia, FGID

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment based on subtypes: Epigastric Pain Syndrome (EPS)
Arm Type
Experimental
Arm Description
EPS: treat with esomeprazole 40mg OD (proton pump inhibitor)
Arm Title
Treatment based on subtypes: Post Prandial Distress Syndrome (PDS)
Arm Type
Experimental
Arm Description
PDS: treat with itopride 50mg TDS (prokinetic)
Arm Title
Treatment based on subtypes: Overlapped EPS/ PDS
Arm Type
Experimental
Arm Description
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)
Arm Title
Treatment with Proton Pump Inhibitor regardless of subtype
Arm Type
Active Comparator
Arm Description
Treat with esomeprazole 40mg OD (proton pump inhibitor) regardless of subtype of functional dyspepsia
Intervention Type
Drug
Intervention Name(s)
Treatment based on subtypes: Esomeprazole or Itopride
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Treatment with proton pump inhibitor regardless of subtype: Esomeprazole
Intervention Description
Esomeprazole 40mg OD
Primary Outcome Measure Information:
Title
Global symptom change in patients with FD when managed according to guidelines, compare to routine practice
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Individual upper gastrointestinal (UGI) symptoms change
Description
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.
Time Frame
8 weeks
Title
Change of quality of life
Description
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.
Time Frame
8 weeks
Title
Incidence of Adverse effects
Description
Incidence of adverse events of treatment will be assessed.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kee-Huat Chuah, MBBS
Phone
+60379492965
Email
chuah319@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kee-Huat Chuah
Organizational Affiliation
University Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kee Huat Chuah, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients

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