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Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients

Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients: A Multicenter, Comparative Study

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05786807
Enrollment
315
Registered
2023-03-28
Start date
2022-03-07
Completion date
2023-12-31
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori-positive With Functional Dyspepsia

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.

Interventions

DRUGK-CAB

Tegoprazan 50 mg 1 tab twice daily Amoxicillin 500mg 2 cap twice daily Clarithromycin 500mg 1tab twice daily

Sponsors

Wonkwang University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Rate of disappearance of dyspepsia symptomsDay 176Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment

Secondary

MeasureTime frameDescription
Improvement rate of dyspepsia symptomsDay 92, Day 176Change rate of dyspepsia symptoms after 3 months and 6 months of eradication treatment
Number of days of dyspepsia drug administrationDay 92, Day 176Number of days of dyspepsia drug administration after 3 months and 6 months of eradication treatment compared to baseline

Countries

South Korea

Contacts

Primary ContactNam Suk Lee
namsuk2580@daum.net010-9437-4490
Backup ContactJong Min Lee

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026