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

Phase 4

Recruiting

• Conditions: Helicobacter Pylori-positive With Functional Dyspepsia
• Interventions: Drug: K-CAB

• Registration Number: NCT05786807
• Lead Sponsor: Wonkwang University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-07
• Study First Submitted: 2023-02-24
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-03-28
• Last Update Posted: 2023-03-28
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 315

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tegoprazan 50mg	K-CAB	single group

Primary Outcome Measures

Name	Time	Method
Rate of disappearance of dyspepsia symptoms	Day 176	Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment

Secondary Outcome Measures

Name	Time	Method
Improvement rate of dyspepsia symptoms	Day 92, Day 176	Change rate of dyspepsia symptoms after 3 months and 6 months of eradication treatment
Number of days of dyspepsia drug administration	Day 92, Day 176	Number of days of dyspepsia drug administration after 3 months and 6 months of eradication treatment compared to baseline

Trial Locations

Locations (1)

Wonkwang University Hospital; 🇰🇷 Iksan, Jeollabuk, Korea, Republic of