Prospective Double-Blinded Randomized Controlled Trial of 12-Weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

August 15, 2007

Last Updated Date

June 23, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00517114 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Compliance [ Time Frame: 4 weeks ]
Adverse effects [ Time Frame: 4 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Gastroesophageal Reflux
Laryngitis

Intervention ^ICMJE

Drug: Rabeprazole 20mg twice daily

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ting Kin Cheung, Dr

(852) 2855 3989

cheungtk@hkucc.hku.hk

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00517114

Responsible Party

Study ID Numbers ^ICMJE

UW04-204 T/526, HARECCTR0500033

Study Sponsor ^ICMJE

Hospital Authority, Hong Kong

Collaborators ^ICMJE

The University of Hong Kong

Investigators ^ICMJE

Principal Investigator:

Paul KY Lam, Dr

Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

Information Provided By

Hospital Authority, Hong Kong

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP