NCT00517114

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

First QC Date

August 15, 2007

Last Update Submit

October 22, 2013

Conditions

Gastroesophageal RefluxLaryngitis

Keywords

Reflux laryngitis

Outcome Measures

Primary Outcomes (1)

  • Symptoms assessment, quality of life.

    12 weeks

Secondary Outcomes (2)

  • Compliance

    4 weeks

  • Adverse effects

    4 weeks

Interventions

Rabeprazole 20mg twice dailyDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory patients with age between 18-80 years old
  • Patients with newly presented laryngitis.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Gastroesophageal RefluxLaryngitis

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesRespiratory Tract InfectionsInfectionsLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Paul KY Lam, Dr

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 16, 2007

Study Start

January 1, 2005

Study Completion

December 1, 2008

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

CN(1)