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

MedlinePlus related topics: GERD

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)

Intervention Details:

Other Name: Losec

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:	Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca
ClinicalTrials.gov Identifier:	NCT00641264 History of Changes
Other Study ID Numbers:	294
Study First Received:	March 18, 2008
Last Updated:	June 10, 2009
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:

Gastroesophageal Reflux
Laryngitis
Regurgitation, Gastric
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases

Respiratory Tract Infections
Otorhinolaryngologic Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012