Prospective Double-Blinded Randomized Controlled Trial of 12-Weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
Information source: Hospital Authority, Hong Kong
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux; Laryngitis
Intervention: Rabeprazole 20mg twice daily (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hospital Authority, Hong Kong Official(s) and/or principal investigator(s):
Paul KY Lam, Dr, Principal Investigator, Affiliation: Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Overall contact:
Ting Kin Cheung, Dr, Phone: (852) 2855 3989, Email: cheungtk@hkucc.hku.hk
Summary
The purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo
in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of
Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. A
questionnaire will be administered by the research assistant of the Department of Medicine
and ENT, Queen Mary hospital. A 12-week course of PPI versus placebo trial will be commenced
and patients' symptoms and signs will be documented at 6-week and 12-week time. The study
will finish after a 12-week course of rabeprazole.
Clinical Details
Official title: Prospective Double-Blinded Randomized Controlled Trial of 12-Weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Symptoms assessment, quality of life.
Secondary outcome: ComplianceAdverse effects
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Ambulatory patients with age between 18-80 years old
- Patients with newly presented laryngitis.
Exclusion Criteria:
- They were under 18 or over 80 years of age
- Has significant concomitant medical disease
- Pregnancy or lactating women
- Chronic cough attributable to known chronic pulmonary or tracheobronchial disease
- Previous glottal surgery, radiotherapy or malignancy
- Acid suppressive therapy within 4 wk prior to recruitment
- Pharyngo-laryngeal infection in the previous 3 months
- Tracheal intubation in previous 12 months
- Immunosuppression and use of inhaled corticosteroid
Locations and Contacts
Ting Kin Cheung, Dr, Phone: (852) 2855 3989, Email: cheungtk@hkucc.hku.hk
Queen Mary Hospital, Hong Kong, China; Recruiting
Wai Man Wong, Dr, Sub-Investigator
Benjamin CY Wong, Dr, Sub-Investigator
William I Wei, Dr, Sub-Investigator
Additional Information
HAREC Clinical Trial Registry
Starting date: January 2005
Ending date: December 2008
Last updated: June 23, 2009
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