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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

Information source: Hospital Authority, Hong Kong
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroesophageal Reflux; Laryngitis

Intervention: Rabeprazole 20mg twice daily (Drug)

Phase: N/A

Status: Completed

Sponsored by: Hospital Authority, Hong Kong

Official(s) and/or principal investigator(s):
Paul KY Lam, Dr, Principal Investigator, Affiliation: Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Symptoms assessment, quality of life.

Secondary outcome:

Compliance

Adverse effects

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): 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

Locations and Contacts

Queen Mary Hospital, Hong Kong, China
Additional Information

HAREC Clinical Trial Registry

Starting date: January 2005
Last updated: October 22, 2013

Page last updated: August 20, 2015

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