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NCT Number: NCT00614536

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

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RABEPRAZOLE SODIUM

Drug

10mg - 20mg tablet once or twice daily for 12weeks

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Regional difference in distribution of symptoms and lesions, and in severity

    Time frame: 12 weeks

  2. LRPD treatment period with rabaprazole sodium

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2008
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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