An Observational Study to Evaluate the Efficacy and Safety of K-CAB Tab./K-CAB ODT(Tegoprazan) in GERD Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorHK inno.N Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
University-affiliated hospitals and general hospitals that administer the investigational drug
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov