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临床试验/NCT00614536
NCT00614536已完成不适用

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

Janssen Korea, Ltd., Korea0 个研究点目标入组 1,142 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,142
主要终点
The change from baseline in RSI and RFS score during LPRD treatment period,

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

001

干预措施: Rabeprazole Sodium (Drug)

结局指标

主要结局

The change from baseline in RSI and RFS score during LPRD treatment period,

时间窗: 12 weeks

次要结局

  • Regional difference in distribution of symptoms and lesions, and in severity(12 weeks)
  • LRPD treatment period with rabaprazole sodium(12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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