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NCT00517114 Clinical Trial

Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients

Gastroesophageal Reflux Clinical Trial

Official title:
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00517114
Other study ID # UW04-204 T/526
Secondary ID HARECCTR0500033
Status Completed
Phase N/A
First received August 15, 2007
Last updated October 22, 2013
Start date January 2005
Est. completion date December 2008

Study information
Verified date October 2013
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rabeprazole 20mg twice daily

Locations
Country Name City State
China Queen Mary Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptoms assessment, quality of life. 12 weeks
Secondary Compliance 4 weeks
Secondary Adverse effects 4 weeks
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