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

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.

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

Intervention(s) in this Clinical Trial

• Drug: Rabeprazole Sodium
  • 10mg - 20mg tablet once or twice daily for 12weeks

Arms, Groups and Cohorts in this Clinical Trial

• : 001

Primary Measures

• The change from baseline in RSI and RFS score during LPRD treatment period,
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Regional difference in distribution of symptoms and lesions, and in severity
  • Time Frame: 12 weeks
    Safety Issue?: No
• LRPD treatment period with rabaprazole sodium
  • Time Frame: 12 weeks
    Safety Issue?: No

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: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Janssen Korea, Ltd., Korea Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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