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

• Sponsor: Wonkwang University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05786807
• Collaborator: (none)
• Enrollment: 315
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.8
• Patients Per Site Per Month: 14.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori-positive With Functional Dyspepsia	Drug: K-CAB	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 315 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients: A Multicenter, Comparative Study
• Actual Study Start Date: Mar 7, 2022
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tegoprazan 50mg single group	Drug: K-CAB; Tegoprazan 50 mg 1 tab twice daily Amoxicillin 500mg 2 cap twice daily Clarithromycin 500mg 1tab twice daily

Outcome Measures

Primary Outcome Measures

1. Rate of disappearance of dyspepsia symptoms [Day 176]

   Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment

Secondary Outcome Measures

1. Improvement rate of dyspepsia symptoms [Day 92, Day 176]

   Change rate of dyspepsia symptoms after 3 months and 6 months of eradication treatment

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wonkwang University Hospital	Iksan	Jeollabuk	Korea, Republic of	15865

Sponsors and Collaborators

• Wonkwang University Hospital

Investigators

• Principal Investigator: Suck Chei Choi, Wonkwang University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suck Chei Choi, Coordinating Investigator, Wonkwang University Hospital
• ClinicalTrials.gov Identifier: NCT05786807
• Other Study ID Numbers: KCAB_004
• First Posted: Mar 28, 2023
• Last Update Posted: Mar 28, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyspepsia

Study Results

No Results Posted as of Mar 28, 2023