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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00517114
First received: August 15, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
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

ClinicalTrials.gov Identifier: NCT00517114     History of Changes
Other Study ID Numbers: UW04-204 T/526, HARECCTR0500033
Study First Received: August 15, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Reflux laryngitis

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngitis
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013