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

NCT07678177 | Recruiting

• 1 other identifier: IN_TPZ_N03
• Study Type: observational
• Target: 5,384
• Locations: 1 country
• Sites: 1

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.

Conditions

GERD (Gastroesophageal Reflux Disease)

Keywords

IN_TPZ_N03

Outcome Measures

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).

  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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University-affiliated hospitals and general hospitals that administer the investigational drug

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

HK inno.N

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

yong an jeong

CONTACT

82-31-5176-4673; yongan.jeong@inno-n.com

seung gye cho

CONTACT

82-31-5176-4676; seungkye.cho@inno-n.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: March 7, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)