Quality of Life Validation in Laryngitis

Laryngopharyngeal Reflux (LPR) Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641264
• Other study ID #: 294
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: June 10, 2009
• Start date: May 2001
• Est. completion date: June 2003

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Laryngopharyngeal Reflux
• Laryngopharyngeal Reflux (LPR)

Intervention

Drug:
• Omeprazole

Behavioral:
• Quality of Life questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety assessments via adverse event recording and physical examinations		2 monthly