Official Title: “Observational Study: Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period”

The purpose of this observational study is to examine RSI(Reflux Symptom Index) and RFS(Reflux Finding Score) by treatment period before and after rabeprazole treatment in LaryngoPharyngeal Reflux Disease(LPRD) patients.

Study Type: Observational

Study Design: Prospective

This observational study will examine RSI(Reflux Symptom Index) and RFS(Reflux Finding Score) by treatment period before and after rabeprazole treatment in LaryngoPharyngeal Reflux Disease(LPRD) patients. Based on the examination above, this study will explore the correlation between RSI and RFS and will examine major reflux symptoms and types of lesions to find the factors which should be more weighted factors in diagnosing LPRD and judging therapeutic effectiveness. LPRD (Laryngopharyngeal reflux disease) is the disease with various symptoms and lesions caused by exposure of gastric acid and contents to the upper respiratory system.Unlike gastroesophageal reflux disease with the presenting symptoms of heartburn, burning sensation, ardor, reflux, etc., the chief complaints of patients with LPRD include dysphonia, chronic cough, foreign body sensation of pharyngolarynx and orthostatic reflux. LPRD is related to various otorhinolaryngological diseases including acute/chronic laryngitis, aryngostenosis, recurrent laryngismus and subglottic stenosis.

LPRD can be diagnosed through close inquiry, empirical treatment, observance of mucosal lesion or change with gastroendoscope or laryngendoscope and definite diagnosis of reflux with a 24-hour double pH monitoring. However, each test has diagnosis capacity limit to some degree. A 24-hour double pH monitoring known as a test for definite diagnosis especially takes a lot of time and money and its false positive rate is high. Therefore, it is today's tendency to perform a 24-hour double pH monitoring in order to evaluate appropriateness of a therapeutic drug.RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) devised by Belafsk can be used to diagnose LPRD in a relatively objective manner by scoring items of symptoms and lesions peculiar to LPRD.

one tablet of rabeprazole 10 mg or 20 mg once daily for 12 weeks

Inclusion Criteria:

• Patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux
• Patients who need rabeprazole treatment according to the doctor's discretion
• Patients who have signed an informed consent document indicating that they understand the purpose of and procedures required for the observational study and they agree to provide their information

Exclusion Criteria:

• Patients who took rabeprazole within the past one month
• Patients who are hypersensitive to any of rabeprazole or benzimidazole
• Patients with severe hepatic impairment
• Pregnant or lactating women

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen Korea, Ltd., Korea

Overall Clinical Trial Officials and Contacts

Janssen Korea, Ltd. Clinical Trial Study Director Janssen Korea, Ltd., Korea  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00614536

Study ID Number: CR014812

ClinicalTrials.gov Identifier: NCT00614536

Health Authority: Korea: Food and Drug Administration