Back to resultsProspective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
Primary Purpose
Gastroesophageal Reflux, Laryngitis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rabeprazole 20mg twice daily
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Reflux laryngitis
Eligibility 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
Sites / Locations
- Queen Mary Hospital
Outcomes
Primary Outcome Measures
Symptoms assessment, quality of life.
Secondary Outcome Measures
Compliance
Adverse effects
Full Information
NCT ID
NCT00517114
First Posted
August 15, 2007
Last Updated
October 22, 2013
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00517114
Brief Title
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Laryngitis
Keywords
Reflux laryngitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rabeprazole 20mg twice daily
Primary Outcome Measure Information:
Title
Symptoms assessment, quality of life.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Compliance
Time Frame
4 weeks
Title
Adverse effects
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul KY Lam, Dr
Organizational Affiliation
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
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