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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00614536

Enrollment

1142

Registered

2008-02-13

Start date

2007-09-30

Completion date

2008-04-30

Last updated

2014-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux, Pharyngeal Diseases

Keywords

Reflux Symptom Index, Reflux Finding Score, Rabeprazole, LaryngoPharyngeal Reflux Disease, GastroEsophageal Reflux Disease

Brief 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.

Detailed description

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

Interventions

DRUGRabeprazole Sodium

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The change from baseline in RSI and RFS score during LPRD treatment period,	12 weeks

Secondary

Measure	Time frame
Regional difference in distribution of symptoms and lesions, and in severity	12 weeks
LRPD treatment period with rabaprazole sodium	12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026