Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)NCT07920679
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
An observational study of Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD), run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to assess heartburn and acid regurgitation symptoms during long-term administration of K-CAB Tab/K-CAB ODT(Tegoprazan) 25 mg in patients with GERD in routine clinical practice. The study will also evaluate safety information, including important potential risks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
- How many people
- 12,868 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Aug 2025to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University-affiliated hospitals and general hospitals where the study drug is administered
Who may be able to join
- Aged 19 years or older on the date written informed consent is obtained
- Determined by the investigator, based on medical judgment, to receive K-CAB Tab/K-CAB ODT 25 mg
- Scheduled to receive K-CAB Tab/K-CAB ODT 25 mg, as maintenance therapy following treatment for gastroesophageal reflux disease (GERD)
- Voluntarily agrees to participate in the study and provides written informed consent
Who cannot join
- Individuals who meet any of the contraindications listed under "Contraindications" in the "Precautions for Use" section of the approved prescribing information for K-CAB Tab/K-CAB ODT 25 mg
- Individuals whom the investigator considers unsuitable for participation in this study for any other reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
HK inno.N
Seoul
Seung Kye Cho, +82-31-5176-4676, seungkye.cho@inno-n.com
Ahrong Kim, +82-31-5176-4666, ahrong.kim@inno-n.com
About this study
Official title: A Multicenter, Prospective, Observational Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT 25 mg as Maintenance Therapy Following the Treatment of GERD
This study aims to assess heartburn and acid regurgitation symptoms during long-term administration of K-CAB Tab/K-CAB ODT(Tegoprazan) 25 mg in patients with GERD in routine clinical practice. The study will also evaluate safety information, including important potential risks.
Read the detailed description
This study will be conducted in a routine clinical practice setting among patients with gastroesophageal reflux disease who receive maintenance treatment following GERD treatment. Participants will receive long-term administration of either K-CAB tablets 25 mg or K-CAB orally disintegrating tablets 25 mg, as prescribed in clinical practice.
The study will assess the presence of heartburn and acid regurgitation symptoms during maintenance treatment. It will also collect and review safety information, including information related to important potential risks.
- Keywords
- K-CAB, Tegoprazan, K-CAB 25mg, Tegoprazan 25mg, GERD, maintenance treatment
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of study participants with a Korean Gastroesophageal Reflux Disease Questionnaire (GerdQ) score below 8 at Week 24 after administration of K-CAB Tab/K-CAB ODT 25 mg
A GerdQ score below 8 is defined as no recurrence of GERD
Measured: At Week 24 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start14 Aug 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)Studies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12,868 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920679
- Sponsor's protocol ID
- IN_TPZ_N04
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT 25 mg as Maintenance Therapy Following the Treatment of GERD
- ClinicalTrials.gov ID
- NCT07920679
- Acronym / sponsor ID
- IN_TPZ_N04
- Keywords
- K-CAB, Tegoprazan, K-CAB 25mg, Tegoprazan 25mg, GERD, maintenance treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,868 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 6 Nov 2026 (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.
This study aims to assess heartburn and acid regurgitation symptoms during long-term administration of K-CAB Tab/K-CAB ODT(Tegoprazan) 25 mg in patients with GERD in routine clinical practice. The study will also evaluate safety information, including important potential risks.
Detailed description
This study will be conducted in a routine clinical practice setting among patients with gastroesophageal reflux disease who receive maintenance treatment following GERD treatment. Participants will receive long-term administration of either K-CAB tablets 25 mg or K-CAB orally disintegrating tablets 25 mg, as prescribed in clinical practice.
The study will assess the presence of heartburn and acid regurgitation symptoms during maintenance treatment. It will also collect and review safety information, including information related to important potential risks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University-affiliated hospitals and general hospitals where the study drug is administered
Key inclusion criteria (4 listed)
- Aged 19 years or older on the date written informed consent is obtained
- Determined by the investigator, based on medical judgment, to receive K-CAB Tab/K-CAB ODT 25 mg
- Scheduled to receive K-CAB Tab/K-CAB ODT 25 mg, as maintenance therapy following treatment for gastroesophageal reflux disease (GERD)
- Voluntarily agrees to participate in the study and provides written informed consent
Key exclusion criteria (2 listed)
- Individuals who meet any of the contraindications listed under "Contraindications" in the "Precautions for Use" section of the approved prescribing information for K-CAB Tab/K-CAB ODT 25 mg
- Individuals whom the investigator considers unsuitable for participation in this study for any other reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of study participants with a Korean Gastroesophageal Reflux Disease Questionnaire (GerdQ) score below 8 at Week 24 after administration of K-CAB Tab/K-CAB ODT 25 mg
Time frame: At Week 24 after enrollment
A GerdQ score below 8 is defined as no recurrence of GERD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD), run by HK inno.N Corporation 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong-an Jeong (+82-31-5176-4673, yongan.jeong@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of study participants with a Korean Gastroesophageal Reflux Disease Questionnaire (GerdQ) score below 8 at Week 24 after administration of K-CAB Tab/K-CAB ODT 25 mg (time frame: At Week 24 after enrollment). 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 6 Nov 2026.