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
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004401
- Lead Sponsor
- Daegu Catholic University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of day which abscence of main NERD symptom (heartburn and reflux) during 8 weeks
- Secondary Outcome Measures
Name Time Method 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