None listed
Conditions
Interventions
Drug : Test drug: CJ Health Care Co., Ltd. K cap tablet 50mg (Tegoprazan) once a day for 8 weeks
Control: CJ Health Care Co., Ltd. K-Cap tablet 50mg (Tegoprazan) Placebo once daily for 8 weeks
Sponsors
Pusan National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age > 19 2. Sx of LPRD(hoarsness, frequent throat clearing, globus, sore throat or chronic cough) 3. RSI = 13, RFS = 7 4. Patient who understand given information and write questionnaire. 5. Those who voluntarily decide to participate in this clinical trial and give written consent
Exclusion criteria
Exclusion criteria: 1. viral or bacterial laryngopharyngitis 2. patient who had history of malignancy in pharynx/larynx/esophagus/stomach 3. A person who has had radiation therapy in the neck area in the past or has had a bronchial intubation within the last 3 months. 4.Those who have undergone gastric acid suppression surgery or gastric and esophageal surgery (except simple perforation surgery, appendectomy, and benign tumor resection using an endoscope) 5. People with bipolar disorder, anxiety disorders, airport disorders, somatoform disorders, personality disorders, and other psychiatric disorders 6. People taking antipsychotic drugs, antidepressants, or anti-anxiety drugs 7. Those who have taken gastric acid inhibitors such as proton pump inhibitor (PPI) within the last 4 weeks as of Visit 1 8. Patients who have taken medications related to gastroesophageal reflux disease (H2 receptor blockers, prostaglandins, mucosal protection, gastrointestinal motility, etc.) within the last 2 weeks as of Visit 1 9. Patients who need to take non-steroidal anti-inflammatory drugs continuously during the test period (however, low-dose [100 mg or less per day] aspirin taken for preventive purposes before participation in clinical trials is permitted) 10. Pregnant women, lactating women or women of childbearing potential who did not agree to use the appropriate contraceptive method during the trial period (? Appropriate contraceptive methods: condoms, oral contraceptives, injectable or injectable contraceptives, intrauterine contraceptives installed, etc.) 11. A person who showed clinically significant abnormality in the screening test -AST, ALT, ALP, ?-GT, total bilirubin levels are more than twice the upper limit -BUN and creatinine levels are more than 1.5 times the upper limit 12. Patients with clinically significant abnormal ECG -Major arrhythmia, multifocal PVC, 2°AV-block or more 13. Those who have a history of malignant tumors within the last 5 years (however, those who have been judged to have complete remission of the tumor and have passed more than 5 years without recurrence from the date of determination, and tumors removed through endoscopic resection within 3 years) Those without this are excluded) 14. Those who have clinically significant disorders in the liver, kidneys, cardiovascular system, respiratory system, endocrine system, and central nervous system 15. A person with a history of hypersensitivity to an allergic disease or component of a test drug or a specific drug 16. A person who has received another clinical trial drug within 3 months from the time of written consent. 17. Those who are judged not to be suitable for this clinical trial by the investigator's judgment 18. Persons who are receiving atazanavir, nelfinavir, or lilipyrin-containing preparations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who completely improved symptoms(hoarsness/throat clearing/posterior nasal drip/dysphagia/cough after food ingestion or at supine position/dyspnea/annoying cough/globus/hearburn) of LPRD after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects who completely improved symptoms(hoarsness/throat clearing/posterior nasal drip/dysphagia/cough after food ingestion or at supine position/dyspnea/annoying cough/globus/hearburn) of LPRD after 4 weeks | — |
Countries
Korea, Republic of
Contacts
Public ContactSungchan Shin
Pusan National University Hospital
Outcome results
None listed