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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614536
• Other study ID #: CR014812
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2008
• Last updated: April 24, 2014
• Start date: September 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2014
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1142
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Pharyngeal Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in RSI and RFS score during LPRD treatment period,		12 weeks	No
Secondary	Regional difference in distribution of symptoms and lesions, and in severity		12 weeks	No
Secondary	LRPD treatment period with rabaprazole sodium		12 weeks	No