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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Laryngitis

Keywords

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Reflux laryngitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rabeprazole 20mg twice daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Paul KY Lam, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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HARECCTR0500033

Identifier Type: -

Identifier Source: secondary_id

UW04-204 T/526