NCT00641264

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2001

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

Enrollment Period

2.1 years

First QC Date

March 18, 2008

Last Update Submit

June 10, 2009

Conditions

Laryngopharyngeal Reflux (LPR)

Keywords

Laryngopharyngeal reflux (LPR)OmeprazoleLosecQuality of LifeLaryngitis

Outcome Measures

Primary Outcomes (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

    2 monthly

Secondary Outcomes (1)

  • Safety assessments via adverse event recording and physical examinations

    2 monthly

Interventions

OmeprazoleDRUG
Also known as: Losec
Quality of Life questionnaireBEHAVIORAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New Laryngopharyngeal reflux diagnosis less than 1 month or relapsed patients not under current treatment

You may not qualify if:

  • Unable to comply with study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Laryngopharyngeal RefluxLaryngitis

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Gastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsInfectionsOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Paula Fernstrom

    Nexium Global Product Director, AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

May 1, 2001

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

June 11, 2009

Record last verified: 2009-06