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

Wonkwang University Hospital

Status and phase: Enrolling; Phase 4

Conditions: Helicobacter Pylori-positive With Functional Dyspepsia

Treatments: Drug: K-CAB

Study type: Interventional

Funder types: Other

Identifiers

NCT05786807

KCAB_004

Details and patient eligibility

About

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.

Enrollment: 315 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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315 participants in 1 patient group

Tegoprazan 50mg

Experimental group

Description:

single group

Treatment:

Drug: K-CAB