ClinicalTrials.gg
CompletedNCT00641264Updated Jun 11, 2009

Quality of Life Validation in Laryngitis

A Phase 4 interventional study of Omeprazole and Quality of Life questionnaire in Laryngopharyngeal Reflux (LPR), sponsored by AstraZeneca. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-06-11.

Sponsored by AstraZeneca · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Laryngopharyngeal Reflux (LPR)

Keywords

  • Laryngopharyngeal reflux (LPR)
  • Omeprazole
  • Losec
  • Quality of Life
  • Laryngitis
03

In context

Laryngopharyngeal Reflux

56 studies on the registry are indexed under Laryngopharyngeal Reflux; 8 are open to participants now.

This study's planned enrollment of 90 is above the median of 72 across 41 interventional studies indexed under Laryngopharyngeal Reflux.

Browse Laryngopharyngeal Reflux studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unable to comply with study requirements.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Interventions

  • Also known as: Losec

  • BehavioralQuality of Life questionnaire
06

What researchers measure

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

    Time frame: 2 monthly

Secondary outcomes

  1. Safety assessments via adverse event recording and physical examinations

    Time frame: 2 monthly

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00641264
Lead sponsor
AstraZeneca
First posted
Mar 24, 2008
Start date
May 2001
Primary completion
Jun 2003
Completion
Jun 2003
Last update
Jun 11, 2009

Study contacts

Paula Fernstrom
study director · Nexium Global Product Director, AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Omeprazole

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