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

This study is currently recruiting participants.

Verified by Hospital Authority, Hong Kong, June 2008

First Received: August 15, 2007 Last Updated: June 23, 2009 History of Changes

Sponsors and Collaborators:	Hospital Authority, Hong Kong The University of Hong Kong
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00517114

Purpose

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.

Condition	Intervention
Gastroesophageal Reflux Laryngitis	Drug: Rabeprazole 20mg twice daily

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Double-Blinded Randomized Controlled Trial of 12-Weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: E 3810

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2008

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517114

Contacts

Contact: Ting Kin Cheung, Dr

(852) 2855 3989

cheungtk@hkucc.hku.hk

Locations

China
Queen Mary Hospital	Recruiting
Hong Kong, China
Sub-Investigator: Wai Man Wong, Dr
Sub-Investigator: Benjamin CY Wong, Dr
Sub-Investigator: William I Wei, Dr

Sponsors and Collaborators

Hospital Authority, Hong Kong

The University of Hong Kong

Investigators

Principal Investigator:

Paul KY Lam, Dr

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

More Information

Additional Information:

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	UW04-204 T/526, HARECCTR0500033
Study First Received:	August 15, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00517114 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

Reflux laryngitis

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Gastrointestinal Diseases
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Respiratory Tract Diseases

Respiratory Tract Infections
Esophageal Disorder
Laryngitis
Esophageal Diseases
Laryngeal Diseases
Rabeprazole

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders

Digestive System Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Anti-Ulcer Agents
Laryngitis
Esophageal Diseases
Laryngeal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on July 06, 2009