Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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This clinical study is a multicenter, open-label, prospective, observational study of outpatients who visit the department of otolaryngology (branch of medicine that deals with diagnosis and treatment of diseases of the ear, nose, and throat) under routine practice. This study will examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period (before and after rabeprazole treatment) in patients with LaryngoPharyngeal Reflux Disease(LPRD). Among the patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux, those needing rabeprazole sodium treatment according to the doctor's discretion are eligible for enrollment. This study will explore the correlation between RSI and RFS and will examine major reflux symptoms and types of lesions, to find the most reliable factors in diagnosing LPRD and judging therapeutic effectiveness of treatments. LPRD is a disease with various symptoms and causes lesions by exposing the upper respiratory system to gastric acid and stomach contents. RSI and RFS can be used to diagnose LPRD in a relatively objective manner by scoring items of symptoms and lesions particular to LPRD. Evaluations will be performed four times from baseline to week 12. Observational Study - one tablet of rabeprazole 10 mg or 20 mg once daily for 12 weeks

Conditions

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Gastroesophageal Reflux Pharyngeal Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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001

Rabeprazole Sodium

Intervention Type DRUG

10mg - 20mg tablet once or twice daily for 12weeks

Interventions

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Rabeprazole Sodium

10mg - 20mg tablet once or twice daily for 12weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No