A Multi-center, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of K-Cab (Tegoprazan) as Symptomatic Maintenance Therapy in Patients with NERD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004401

Enrollment

130

Registered

2019-10-30

Start date

2020-01-17

Completion date

Unknown

Last updated

2025-09-22

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

Conditions

None listed

Interventions

Drug : To evaluate the efficacy for the maintenance therapy in NERD patients, who showed heartburn or reflux symptom twice or more times in a week and these patients who improved these symptoms after

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The age 19-65 years old 2. The patients who had a history of heartburn or regurgitation with a frequency of at least 2 episodes per week and diagnosed NERD of endoscopic finding (LA classification) 3. Wrritten informed consent was obtained from all participants

Exclusion criteria

Exclusion criteria: 1. The patients who cannot endoscopic examination 2. The patients who had an esophageal stricture, ulcer, reflus esophagitis, barret’s esophagus, active or healing stage peptic ulcer, gastrointestinal bleeding, and eosinophilic esophagitis 3. The patients who had gastrointestinal carcinoid tumor and history of endoscopic resection 4. patients who had an erosive reflux disease, gastrointestinal bleeding, active or healing stage peptic ulcer, gastritis, in the last 2 months. 5. History of drug and alcohol abuse 6. History of esophagus, stomach, duodenal surgery (exclusion, history of appendectomy and cholcystectomy) 7. History of malignancy in 5 years 8. History of allergy to antacid, proton pump inhibitor, potassium-competitive acid blocker and relating the clinical medication or silmilar drug 9. History of allergy to penicillin 10. Medication to perphenadine, cisapride, pymozid, astemizol 11. History of allergy to macrolide 12. who is being pregnant or lactating 13. Mental neuropathy patients (manic patients, etc.), alcoholics, drug dependence (central nervous system inhibitors, etc.) 14. Medication of HIV protease inhibitor or Rilpivirine ?? ??? ?? ?? ? 15. Abnormal serologic test - over than UNL 2 or more times AST, ALT, ALP, ?-GT, total bilirubin - over than UNL 1.5 or more times BUN, creatinine 16. Zollinger-Ellison syndrome patients 17. Patients with severe systemic disorders of the heart, lungs, blood and endocrine system 18. If the researcher judges that he / she is not suitable for participation other than the above items.

Design outcomes

Primary

Measure	Time frame
The rate of day which abscence of main NERD symptom (heartburn and reflux) during 8 weeks	—

Secondary

Measure	Time frame
Mean change of GSRS score at week 2, 4 and 8 relative baseline;Mean change of GERD-HRQL score at week 8 relative baseline;The rate of day which abscence of NERD symptom during 8 weeks;The rate of patients who showed improving main NERD symptom at 2, 4 and 8 weeks	—

Countries

Korea, Republic of

Contacts

Public ContactYonghwan Kwon

Kyungpook National University Medical Center

tear9754006@yahoo.co.kr@tear9754006@yahoo.co+82-53-200-2609

Outcome results