Helicobacter Pylori-positive With Functional DyspepsiaPhase 4NCT05786807
Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients
A Phase 4 study testing K-CAB in people with Helicobacter Pylori-positive With Functional Dyspepsia, run by Wonkwang University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Helicobacter Pylori-positive With Functional Dyspepsia
- What is being tested?
- K-CAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Mar 2022to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Jong Min Lee contact
South Korea1 site, 1 recruiting
- Recruiting
Wonkwang University Hospital
Iksan, Jeollabuk, 15865
Suck Chei Choi
About this study
Official title: Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients: A Multicenter, Comparative Study
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.
- Being tested
- K-CAB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-CABDrug
Tegoprazan 50 mg 1 tab twice daily Amoxicillin 500mg 2 cap twice daily Clarithromycin 500mg 1tab twice daily
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50mg | Experimental | single group Receives: Drug: K-CAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of disappearance of dyspepsia symptoms
Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment
Measured: Day 176
Secondary outcomes (2)
Improvement rate of dyspepsia symptoms
Change rate of dyspepsia symptoms after 3 months and 6 months of eradication treatment
Measured: Day 92, Day 176
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
Measured: Day 92, Day 176
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start7 Mar 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori-positive With Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suck Chei Choi, Wonkwang University Hospital
- Investigators
- Suck Chei Choi, Principal investigator, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786807
- Sponsor's protocol ID
- KCAB_004
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients: A Multicenter, Comparative Study
- ClinicalTrials.gov ID
- NCT05786807
- Acronym / sponsor ID
- KCAB_004
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan 50mg | Experimental | Drug: K-CABsingle group |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-CABTegoprazan 50 mg 1 tab twice daily Amoxicillin 500mg 2 cap twice daily Clarithromycin 500mg 1tab twice daily | Drug | Tegoprazan 50mg |
Primary outcome
Rate of disappearance of dyspepsia symptoms
Time frame: Day 176
Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment
2 secondary outcomes
Improvement rate of dyspepsia symptoms
Time frame: Day 92, Day 176
Number of days of dyspepsia drug administration
Time frame: Day 92, Day 176
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Min Lee contact
Suck Chei Choi principal investigator
Wonkwang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing K-CAB in people with Helicobacter Pylori-positive With Functional Dyspepsia, run by Wonkwang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nam Suk Lee (010-9437-4490, namsuk2580@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of disappearance of dyspepsia symptoms (time frame: Day 176). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.