An Observational Study to Evaluate the Efficacy and Safety of K-CAB Tab./K-CAB ODT(Tegoprazan) in GERD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: GERD (Gastroesophageal Reflux Disease). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of K-CAB Tab./K-CAB ODT(Tegoprazan) in GERD Patients
Overview
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).
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- HK inno.N — Seoul
Identifiers
NCT: NCT07678177 · IN_TPZ_N03