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Quality of Life Validation in Laryngitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00641264
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : June 11, 2009
Sponsor:
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Laryngopharyngeal Reflux (LPR) Drug: Omeprazole Behavioral: Quality of Life questionnaire Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2001
Primary Completion Date : June 2003
Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Omeprazole
    Other Name: Losec
    Behavioral: Quality of Life questionnaire

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Safety assessments via adverse event recording and physical examinations [ Time Frame: 2 monthly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641264


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
More Information

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca
ClinicalTrials.gov Identifier: NCT00641264     History of Changes
Other Study ID Numbers: 294
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
Laryngopharyngeal reflux (LPR)
Omeprazole
Losec
Quality of Life
Laryngitis

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Laryngitis
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
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action