CClinicalTrials.gg
Status unknownNCT05786807Updated Mar 28, 2023

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

A Phase 4 interventional study of K-CAB in Helicobacter Pylori-positive With Functional Dyspepsia, sponsored by Wonkwang University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Wonkwang University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2022, registered Feb 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
315
Allocation
Not applicable
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Helicobacter Pylori-positive With Functional Dyspepsia

Browse trials for

03

In context

Dyspepsia

363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's planned enrollment of 315 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Wonkwang University Hospital is the lead sponsor of 26 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
315 participants (estimated)

Study arms

  • Experimental
    Tegoprazan 50mg

    single group

    Drug: K-CAB

Interventions

  • DrugK-CAB

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

06

What researchers measure

Primary outcomes

  1. Rate of disappearance of dyspepsia symptoms

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

    Time frame: Day 176

Secondary outcomes

  1. Improvement rate of dyspepsia symptoms

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

    Time frame: Day 92, Day 176

  2. Number of days of dyspepsia drug administration

    Number of days of dyspepsia drug administration after 3 months and 6 months of eradication treatment compared to baseline

    Time frame: Day 92, Day 176

07

Study locations

1 of 1 sites recruiting
  • Wonkwang University Hospital
    Iksan, Jeollabuk 15865, Korea, Republic of
    • Suck Chei Choi · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05786807
Lead sponsor
Wonkwang University Hospital
Responsible party
Suck Chei Choi (Coordinating Investigator, Wonkwang University Hospital) — Principal investigator
First posted
Mar 28, 2023
Start date
Mar 7, 2022
Primary completion
Nov 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 28, 2023

Study contacts

Nam Suk Lee
Contact
namsuk2580@daum.net
010-9437-4490
Jong Min Lee
Contact
Suck Chei Choi
principal investigator · Wonkwang University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion