Official Title: “Prospective Double-Blinded Randomized Controlled Trial of 12-Weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rabeprazole 20mg twice daily

Primary Measures

• Symptoms assessment, quality of life.
  • Time Frame: 12 weeks
    

Secondary Measures

• Compliance
  • Time Frame: 4 weeks
    
• Adverse effects
  • Time Frame: 4 weeks
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Lead Sponsor: Hospital Authority, Hong Kong

Overall Clinical Trial Officials and Contacts

Paul KY Lam, Dr Principal Investigator Department of Medicine, Queen Mary Hospital/ The University of Hong Kong  

Overall Contact: Ting Kin Cheung, Dr (852) 2855 3989 cheungtk@hkucc.hku.hk

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00517114

Study ID Number: UW04-204 T/526

ClinicalTrials.gov Identifier: NCT00517114

Health Authority: Hong Kong: Ethics Committee

HAREC Clinical Trial Registry