Effect of H. Pylori Eradication on Alleviating Symptoms i... | NCT05786807

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

NCT05786807

Sponsor

Wonkwang University Hospital

Status

Unknown status

Last Update Posted

Mar 28, 2023Actual

Enrollment

315Estimated

Phase

Phase 4

Conditions

Helicobacter Pylori-positive With Functional Dyspepsia

Interventions

K-CAB

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2022Actual

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Feb 24, 2023

First Submission Date that Met QC Criteria

Mar 27, 2023

First Posted Date

Mar 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2023

Last Update Posted Date

Mar 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Suck Chei Choi, Coordinating Investigator, Wonkwang University HospitalPrincipal Investigator

Lead Sponsor

Wonkwang University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

315Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tegoprazan 50mg	Experimental	single group	Drug: K-CAB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
K-CAB	Drug	Tegoprazan 50 mg 1 tab twice daily Amoxicillin 500mg 2 cap twice daily Clarithromycin 500mg 1tab twice daily	Tegoprazan 50mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of disappearance of dyspepsia symptoms	Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment	Day 176

Secondary Outcomes

Measure	Description	Time Frame
Improvement rate of dyspepsia symptoms	Change rate of dyspepsia symptoms after 3 months and 6 months of eradication treatment	Day 92, Day 176
Number of days of dyspepsia drug administration

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nam Suk Lee	Contact	010-9437-4490		namsuk2580@daum.net
Jong Min Lee	Contact

Overall Officials

Name	Affiliation	Role
Suck Chei Choi	Wonkwang University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wonkwang University Hospital	Recruiting	Iksan	Jeollabuk	15865	South Korea