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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

H

Hospital Authority, Hong Kong

Status

Completed

Conditions

Laryngitis
Gastroesophageal Reflux

Treatments

Drug: Rabeprazole 20mg twice daily

Study type

Interventional

Funder types

Other

Identifiers

NCT00517114
HARECCTR0500033
UW04-204 T/526

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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