Back to resultsEffect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients
Primary Purpose
Helicobacter Pylori-positive With Functional Dyspepsia
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
K-CAB
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori-positive With Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria: Male and female outpatients between the ages of 19 and 75 Who have symptoms of functional dyspepsia (early fullness, postprandial discomfort, epigastric pain, epigastric soreness) that correspond to Rome criteria 4 (diagnostic criteria questionnaire) Exclusion Criteria: Small intestine and large intestine disease within 6 months of the screening visit (Visit 1) liver, pancreatobiliary disease within 6 months of the screening visit (Visit 1) peptic ulcer within 6 months of the screening visit (Visit 1)
Sites / Locations
- Wonkwang University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tegoprazan 50mg
Arm Description
single group
Outcomes
Primary Outcome Measures
Rate of disappearance of dyspepsia symptoms
Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment
Secondary Outcome Measures
Improvement rate of dyspepsia symptoms
Change rate of dyspepsia symptoms after 3 months and 6 months of eradication treatment
Number of days of dyspepsia drug administration
Number of days of dyspepsia drug administration after 3 months and 6 months of eradication treatment compared to baseline
Full Information
NCT ID
NCT05786807
First Posted
February 24, 2023
Last Updated
March 27, 2023
Sponsor
Wonkwang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05786807
Brief Title
Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients
Official Title
Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients: A Multicenter, Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonkwang University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In patients with Helicobacter pylori-positive functional dyspepsia, long-term follow-up for 6 months after standard triple therapy first-line eradication treatment, the rate of symptom disappearance and degree of improvement of functional dyspepsia were confirmed through changes in symptom scores and changes in drug usage, and eradication treatment The purpose of this study is to confirm the rate of symptom disappearance according to the results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori-positive With Functional Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
315 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tegoprazan 50mg
Arm Type
Experimental
Arm Description
single group
Intervention Type
Drug
Intervention Name(s)
K-CAB
Intervention Description
Tegoprazan 50 mg 1 tab twice daily Amoxicillin 500mg 2 cap twice daily Clarithromycin 500mg 1tab twice daily
Primary Outcome Measure Information:
Title
Rate of disappearance of dyspepsia symptoms
Description
Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment
Time Frame
Day 176
Secondary Outcome Measure Information:
Title
Improvement rate of dyspepsia symptoms
Description
Change rate of dyspepsia symptoms after 3 months and 6 months of eradication treatment
Time Frame
Day 92, Day 176
Title
Number of days of dyspepsia drug administration
Description
Number of days of dyspepsia drug administration after 3 months and 6 months of eradication treatment compared to baseline
Time Frame
Day 92, Day 176
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female outpatients between the ages of 19 and 75
Who have symptoms of functional dyspepsia (early fullness, postprandial discomfort, epigastric pain, epigastric soreness) that correspond to Rome criteria 4 (diagnostic criteria questionnaire)
Exclusion Criteria:
Small intestine and large intestine disease within 6 months of the screening visit (Visit 1)
liver, pancreatobiliary disease within 6 months of the screening visit (Visit 1)
peptic ulcer within 6 months of the screening visit (Visit 1)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nam Suk Lee
Phone
010-9437-4490
Email
namsuk2580@daum.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Min Lee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suck Chei Choi
Organizational Affiliation
Wonkwang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonkwang University Hospital
City
Iksan
State/Province
Jeollabuk
ZIP/Postal Code
15865
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suck Chei Choi
12. IPD Sharing Statement
Learn more about this trial
Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients
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