Quality of Life Validation in Laryngitis | NCT00641264

Studies
Quality of Life Validation in Laryngitis

NCT00641264

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 11, 2009Estimated

Enrollment

90Estimated

Phase

Phase 4

Conditions

Laryngopharyngeal Reflux (LPR)

Interventions

Omeprazole
Quality of Life questionnaire

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2001

Primary Completion Date

Jun 2003Actual

Completion Date

Jun 2003Actual

First Submitted Date

Mar 18, 2008

First Submission Date that Met QC Criteria

Mar 18, 2008

First Posted Date

Mar 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2009

Last Update Posted Date

Jun 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Name	Type	Description	Arm Group Labels	Other Names
Omeprazole	Drug			Losec
Quality of Life questionnaire	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Safety assessments via adverse event recording and physical examinations		2 monthly

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paula Fernstrom	Nexium Global Product Director, AstraZeneca	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057045	Laryngopharyngeal Reflux
D007827	Laryngitis

Ancestor Terms

ID	Term
D005764	Gastroesophageal Reflux
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009853	Omeprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided