ClinicalTrials.gg
RecruitingNCT07678177Updated Jul 1, 2026

An Observational Study to Evaluate the Efficacy and Safety of K-CAB Tab./K-CAB ODT(Tegoprazan) in GERD Patients

An observational study in GERD (Gastroesophageal Reflux Disease), 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 2026-07-01.

Sponsored by HK inno.N Corporation · Observational

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
5,384
Ages
19 Years and older
Sex
All
01

Study summary

This study aims to evaluate the status of AE and improvement effect of K-CAB Tab/K-CAB ODT(Tegoprazan) 50mg in patients with GERD.

Read the detailed description

This is a multi-center, prospective, non-interventional, observational study. Subjects will be prescribed in one of the two formulation groups (K-CAB Tab 50 mg or K-CAB ODT 50 mg).

02

Conditions studied

  • GERD (Gastroesophageal Reflux Disease)

Keywords

  • IN_TPZ_N03
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 5,384 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 that administer the investigational drug

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. Subjects over 19 years of age as of the date of consent
  2. Subjects with a total score of 8 or more in the Korean Gastroesophageal Reflux Disease Questionnaire (GerdQ) based on Visit 1
  3. Subjects who voluntarily decides to participate and agrees in writing to the consent form of the study

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have reactions and a medical history of Benzimidazole or components of the drug
  2. Subjects on Atazanavir, Nelfinavir, or Rilpivirine-containing medications
  3. Pregnant and lactating women
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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
5,384 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Symptom improvement rate at 4 weeks after administration of K-CAB Tablet/K-CAB ODT.

    After administering the K-CAB Tablet/K-CAB ODT for 4 weeks, heartburn and gastric acid reflux symptoms are evaluated using the symptom evaluation score, and the proportion of subjects whose sum of symptom evaluation scores has improved by more than 50%(50% Overall Responder).

    Time frame: From enrollment to the end of treatment at 4 weeks. If symptoms do not disappear at the time of 4 weeks, F/U is added for an additional 4 weeks.

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07678177
Responsible party
Sponsor
First posted
Jul 1, 2026
Start date
Mar 7, 2023
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 1, 2026

Study contacts

yong an jeong
Contact
yongan.jeong@inno-n.com
82-31-5176-4673
seung gye 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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