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

This study has been completed.
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: October 22, 2013
Last verified: October 2013
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China
Queen Mary Hospital
Hong Kong, China
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:
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: October 22, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Reflux laryngitis

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

ClinicalTrials.gov processed this record on August 20, 2014