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
1 other identifier
observational
1,142
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2007
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedApril 28, 2014
April 1, 2014
7 months
January 24, 2008
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change from baseline in RSI and RFS score during LPRD treatment period,
12 weeks
Secondary Outcomes (2)
Regional difference in distribution of symptoms and lesions, and in severity
12 weeks
LRPD treatment period with rabaprazole sodium
12 weeks
Study Arms (1)
001
Interventions
Eligibility Criteria
Among the patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux ; Patients who need rabeprazole treatment according to the doctor's discretion
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd. Clinical Trial
Janssen Korea, Ltd.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 13, 2008
Study Start
September 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
April 28, 2014
Record last verified: 2014-04