Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastroesophageal Reflux Pharyngeal Diseases |
Drug: Rabeprazole Sodium |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Observational Study: Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period |
- The change from baseline in RSI and RFS score during LPRD treatment period, [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Regional difference in distribution of symptoms and lesions, and in severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- LRPD treatment period with rabaprazole sodium [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 1142 |
| Study Start Date: | September 2007 |
| Study Completion Date: | April 2008 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 001 |
Drug: Rabeprazole Sodium
10mg - 20mg tablet once or twice daily for 12weeks
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Among the patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux ; Patients who need rabeprazole treatment according to the doctor's discretion
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Medical Director, Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT00614536 History of Changes |
| Other Study ID Numbers: | CR014812 |
| Study First Received: | January 24, 2008 |
| Last Updated: | April 26, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Reflux Symptom Index Reflux Finding Score Rabeprazole LaryngoPharyngeal Reflux Disease GastroEsophageal Reflux Disease |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Pharyngeal Diseases Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Stomatognathic Diseases |
Otorhinolaryngologic Diseases Rabeprazole Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013