Back to resultsQuality of Life Validation in Laryngitis
Primary Purpose
Laryngopharyngeal Reflux (LPR)
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Omeprazole
Quality of Life questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Laryngopharyngeal Reflux (LPR) focused on measuring Laryngopharyngeal reflux (LPR), Omeprazole, Losec, Quality of Life, Laryngitis
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
LPR-HRQL questionnaire, which measured symptom distress and the effects of LPR on voice, cough, throat clearing, swallow , and overall impact of acid reflux
Secondary Outcome Measures
Safety assessments via adverse event recording and physical examinations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00641264
Brief Title
Quality of Life Validation in Laryngitis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux (LPR)
Keywords
Laryngopharyngeal reflux (LPR), Omeprazole, Losec, Quality of Life, Laryngitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Losec
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life questionnaire
Primary Outcome Measure Information:
Title
LPR-HRQL questionnaire, which measured symptom distress and the effects of LPR on voice, cough, throat clearing, swallow , and overall impact of acid reflux
Time Frame
2 monthly
Secondary Outcome Measure Information:
Title
Safety assessments via adverse event recording and physical examinations
Time Frame
2 monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Fernstrom
Organizational Affiliation
Nexium Global Product Director, AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Quality of Life Validation in Laryngitis
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