Quality of Life Validation in Laryngitis

Laryngopharyngeal Reflux Health Related Quality of Life (LPR-HRQL) Questionnaire Development and Psychometric Testing in Patients Receiving Omeprazole 20 mg Bid as Treatment for Laryngopharyngeal Reflux.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641264

Enrollment

Registered

2008-03-24

Start date

2001-05-31

Completion date

2003-06-30

Last updated

2009-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngopharyngeal Reflux (LPR)

Keywords

Laryngopharyngeal reflux (LPR), Omeprazole, Losec, Quality of Life, Laryngitis

Brief summary

The primary purpose of this study was to establish the psychometric properties of a new disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the questionnaire that were evaluated were: validity, reliability, and responsiveness to change (as a measure of treatment effect).

Interventions

DRUGOmeprazole

BEHAVIORALQuality of Life questionnaire

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* New Laryngopharyngeal reflux diagnosis less than 1 month or relapsed patients not under current treatment

Exclusion criteria

* Unable to comply with study requirements.

Design outcomes

Primary

Measure	Time frame
LPR-HRQL questionnaire, which measured symptom distress and the effects of LPR on voice, cough, throat clearing, swallow , and overall impact of acid reflux	2 monthly

Secondary

Measure	Time frame
Safety assessments via adverse event recording and physical examinations	2 monthly

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026