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NCT Number: NCT07678177

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

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.

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Key information

Conditions

GERD (Gastroesophageal Reflux Disease) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    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.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

seung gye cho

CONTACT

[email protected]

82-31-5176-4676

yong an jeong

CONTACT

[email protected]

82-31-5176-4673

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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