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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

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

August 15, 2007
October 22, 2013
January 2005
Not Provided
Symptoms assessment, quality of life. [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00517114 on ClinicalTrials.gov Archive Site
  • Compliance [ Time Frame: 4 weeks ]
  • Adverse effects [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Gastroesophageal Reflux
  • Laryngitis
Drug: Rabeprazole 20mg twice daily
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2008
Not Provided

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
Both
18 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00517114
UW04-204 T/526, HARECCTR0500033
Not Provided
Not Provided
Hospital Authority, Hong Kong
The University of Hong Kong
Principal Investigator: Paul KY Lam, Dr Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Hospital Authority, Hong Kong
October 2013

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