Is the P-CAB test effective in Patients with Globus?

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 62

Inclusion Criteria

1. Aged 19 years older at the time of signing the informed consent form
2. Who have visited otolaryngology for globus sensation within recent 4 weeks (Note : cases where there is an abnormal medical opinion such as cancer at that time are excluded)
3. Complaining globus sensation more than 4 weeks.
4. No organic lesions or mucosal breaks according to LA classification were observed in upper gastrointestinal endoscopy within the recent 3 months (Note : minimal change can be included).
5. Is normal on thyroid palpation at screening.
6. Is = 6 total score on the globus sensation symptom evaluation questionnaire conducted at screening
7. Voluntarily determines to the study participation and provides written informed consent.
8. Who have agreed to use acceptable contraception methods(including medically unable to be pregnant) during the study
- Women who are medically unable to be pregnant can participate in the study: post-menopausal (no menstruation for =24 months), history of hysterectomy, salpingectomy, or bilateral ovariectomy, etc.
- Medically acceptable methods of contraception : intrauterine devices (loop, Mirena), physical barrier methods (male condom, female condom (femidom)), subdermal contraceptive implants (Implanon, etc.), sustained release injectable contraceptives, salpingectomy and tubal ligation, vasectomy, etc. (oral contraceptives may not be used during the study, and dual contraceptives are recommended to avoid pregnancy during the study.)

Exclusion Criteria

1. Unable to complete a questionnarie by oneself.
2. History of hypersensitivity to potassium-competitive acid ingredients or benzimidazoles.
3. Has warning symptoms indicative of GI malignancy such as odynophagia, severe dysphagia, hemorrhage, weight loss, anemia, or bloody stool (except for hemorrhoids).
Note: if the malignancy is negative through an endoscopy be eligible.
4. Has a history or plan of surgery such as upper GI resection, acid-suppressive surgery, or mucosal resection which may affect acid secretion.
Note: Exceptions of this criterion include simple fenestration, appendectomy, cholecystectomy, hysterectomy, laparoscopic excision of benign tumor or endoscopic excision of benign tumor .
5. Has Zollinger-Ellison syndrome, inflammatory disease (e.g., inflammatory bowel disease such as Crohn’s disease or ulcerative colitis, and pancreatitis).
6. Findings of LA grade A or more erosive esophagitis, esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett’s esophagus with > 3 cm length (LSBE), eosinophilic esophagitis, gastrointestinal bleeding, active digestive ulcer or malignant tumor on upper GI endoscopy.
7. Has a history of malignancy within recent 5 years.
Note: Subjects who had complete response (CR or pCR) without relapse within 5 years from the date of its confirmation and subjects whose tumor had been completely removed by endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) without recurrence within 3 years are eligible.
8. Has a diabetic gastroparesis
9. Is receiving HIV protease inhibitor (atazanavir, nelfinavir) or rilpivirine-containing agent.
10. Has a history of myocardial infarction, severe conduction disorder (arrhythmia, heart block, bundle branch block, complete atrioventricular block), acute delirium, paralytic ileus within recent 3 months
11. Clinically significant abnormalities at the blood chemistry test within recent 3 months
- BUN, creatinine levels: More than 1.5 times institution-specific UNL, Clcr: Less than 30 mL/min
- AST, ALT, ALP, ?-GT, total bilirubin levels: More than 2 times institution-specific upper normal limit (UNL)
12. Clinically significant disorders in the liver, kidney, cardiovascular system, respiratory system, endocrine system, or central nervous system
13. Is receiving drugs(gastrointestinal motility stimulants, acid secretion inhibitors, proton pump inhibitors, non-steroidal anti-inflammatory drugs, anticholinergics) that may affect the efficacy evaluation of the study drug (subjects taking these drugs can participate after treated wash-out period at least 2 weeks).
14. Pregnant, breastfeeding or intending to pregnant.
15. Has participated in other clinical study and received another investigational agent within 12 weeks prior to the Visit 1(screening starting date).
Note: - Current or previous participation in a study conducted in a non-interventional fashion (such as observational study or survey) and thus considered to have no interference with the evaluation of efficacy and safety in the current study at the discretion of the investigator is not excluded.
- A subject who signed the ICF for participating in other study is eligible if the subject has been withdrawn before initiation of any treatment in that study.
16. Has a plan to undergo surgery or surgical procedure requiring hospitalization during the study
17. Is receiving antipsychotics, antidepressants or anti-anxiety medications
18. Has a