Quality of Life Validation in Laryngitis - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00641264

Purpose

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).

Condition	Intervention	Phase
Laryngopharyngeal Reflux (LPR)	Drug: Omeprazole Behavioral: Quality of Life questionnaire	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
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.

Resource links provided by NLM:

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 [ Time Frame: 2 monthly ]

Secondary Outcome Measures:

Safety assessments via adverse event recording and physical examinations [ Time Frame: 2 monthly ]

Estimated Enrollment:	90
Study Start Date:	May 2001
Study Completion Date:	June 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641264

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Responsible Party:	Astra Zeneca ( Tore Lind, MD - Nexium Medical Science Director )
Study ID Numbers:	294
Study First Received:	March 18, 2008
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00641264 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Laryngopharyngeal reflux (LPR)
Omeprazole
Losec
Quality of Life
Laryngitis

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders

Deglutition Disorders
Digestive System Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Anti-Ulcer Agents
Laryngitis
Laryngeal Diseases
Esophageal Diseases

ClinicalTrials.gov processed this record on November 30, 2009