ClinicalTrials.gg
RecruitingNCT07920679Updated Nov 9, 2026

Efficacy and Safety of K-CAB(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD

An observational study in Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD), sponsored by HK inno.N Corporation. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by HK inno.N Corporation · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Nov 9, 2026Title changedNewly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
12,868
Ages
19 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)

Keywords

  • K-CAB
  • Tegoprazan
  • K-CAB 25mg
  • Tegoprazan 25mg
  • GERD
  • maintenance treatment
03

In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's planned enrollment of 12,868 is above the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

HK inno.N Corporation is the lead sponsor of 102 studies on the registry; 17 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

University-affiliated hospitals and general hospitals where the study drug is administered

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 19 years or older on the date written is obtained
  2. Determined by the investigator, based on medical judgment, to receive K-CAB Tab/K-CAB ODT 25 mg
  3. Scheduled to receive K-CAB Tab/K-CAB ODT 25 mg, as maintenance therapy following treatment for gastroesophageal reflux disease (GERD)
  4. Voluntarily agrees to participate in the study and provides written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Individuals who meet any of the listed under "Contraindications" in the "Precautions for Use" section of the approved prescribing information for K-CAB Tab/K-CAB ODT 25 mg
  2. Individuals whom the investigator considers unsuitable for participation in this study for any other reason
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
12,868 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At Week 24 after enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Jun 2030, 58 months after the start.

Of 116 observational studies under Gastroesophageal Reflux, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 167. This study's planned 58 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartActual
Aug 14, 2025
Primary completionEst.
Jun 30, 2030
CompletionEst.
Jun 30, 2030
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Title
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
Nov 9, 2026
Registered
First appeared on the registry
Nov 6, 2026
Show all 2 updates
  1. Nov 9, 2026
    Title 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
  2. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07920679
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Aug 14, 2025
Primary completion
Jun 30, 2030 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Nov 9, 2026

Study contacts

Yong-an Jeong
Contact
yongan.jeong@inno-n.com
+82-31-5176-4673
Seung kye Cho
Contact
seungkye.cho@inno-n.com
+82-31-5176-4676

Oversight

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

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