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

A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of K-CAB Tab./K-CAB ODT(Tegoprazan) in GERD Patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07678177

Enrollment

5384

Registered

2026-07-01

Start date

2023-03-07

Completion date

2027-06-30

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD (Gastroesophageal Reflux Disease)

Keywords

IN_TPZ_N03

Brief 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.

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
Symptom improvement rate at 4 weeks after administration of K-CAB Tablet/K-CAB ODT.	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.	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).

Countries

South Korea

Contacts

CONTACTyong an jeong

yongan.jeong@inno-n.com82-31-5176-4673

CONTACTseung gye cho

seungkye.cho@inno-n.com82-31-5176-4676

Outcome results