Trials / Completed
CompletedNCT00614536
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,142 (actual)
- Sponsor
- Janssen Korea, Ltd., Korea · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rabeprazole Sodium | 10mg - 20mg tablet once or twice daily for 12weeks |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2008-04-01
- Completion
- 2008-04-01
- First posted
- 2008-02-13
- Last updated
- 2014-04-28
Source: ClinicalTrials.gov record NCT00614536. Inclusion in this directory is not an endorsement.