Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period.
Information source: Janssen Korea, Ltd., Korea
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux; Pharyngeal Disease
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s):
Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd., Korea
Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com
Summary
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.
Clinical Details
Official title: Observational Study: Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
Study design: Prospective
Detailed description:
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
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com Additional Information
Last updated: October 31, 2008
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