- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00517114
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
October 22, 2013 updated by: Hospital Authority, Hong Kong
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, China
- Queen Mary Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptoms assessment, quality of life.
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse effects
Time Frame: 4 weeks
|
4 weeks
|
Compliance
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul KY Lam, Dr, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
August 15, 2007
First Submitted That Met QC Criteria
August 15, 2007
First Posted (Estimate)
August 16, 2007
Study Record Updates
Last Update Posted (Estimate)
October 23, 2013
Last Update Submitted That Met QC Criteria
October 22, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Gastrointestinal Diseases
- Otorhinolaryngologic Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Laryngeal Diseases
- Gastroesophageal Reflux
- Laryngitis
- Croup
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Rabeprazole
Other Study ID Numbers
- UW04-204 T/526
- HARECCTR0500033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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