Laryngopharyngeal Reflux (LPR)Phase 4NCT00641264
Quality of Life Validation in Laryngitis
A Phase 4 study testing Omeprazole and Quality of Life questionnaire in people with Laryngopharyngeal Reflux (LPR), run by AstraZeneca.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laryngopharyngeal Reflux (LPR)
- What is being tested?
- Omeprazole and Quality of Life questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2001to Jun 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New Laryngopharyngeal reflux diagnosis less than 1 month or relapsed patients not under current treatment
Who cannot join
- Unable to comply with study requirements.
About this study
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.
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).
- Conditions
- Laryngopharyngeal Reflux (LPR)
- Being tested
- Omeprazole, Quality of Life questionnaire
- Keywords
- Laryngopharyngeal reflux (LPR), Omeprazole, Losec, Quality of Life, Laryngitis
- Medical subject headings
- Laryngopharyngeal Reflux, Laryngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Losec
Quality of Life questionnaireBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
LPR-HRQL questionnaire, which measured symptom distress and the effects of LPR on voice, cough, throat clearing, swallow , and overall impact of acid reflux
Measured: 2 monthly
Secondary outcomes (1)
Safety assessments via adverse event recording and physical examinations
Measured: 2 monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMay 2001
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngopharyngeal Reflux (LPR)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paula Fernstrom, Study director, Nexium Global Product Director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641264
- Sponsor's protocol ID
- 294
- Status last verified
- Jun 2009
- First submitted
- 18 Mar 2008
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00641264
- Acronym / sponsor ID
- 294
- Conditions
- Laryngopharyngeal Reflux (LPR)
- Keywords
- Laryngopharyngeal reflux (LPR), Omeprazole, Losec, Quality of Life, Laryngitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New Laryngopharyngeal reflux diagnosis less than 1 month or relapsed patients not under current treatment
Key exclusion criteria (1 listed)
- Unable to comply with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: Losec | Drug | – |
| Quality of Life questionnaire | Behavioural | – |
Primary outcome
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
1 secondary outcome
Safety assessments via adverse event recording and physical examinations
Time frame: 2 monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
Related trials for Laryngopharyngeal Reflux (LPR)
Active, not recruiting
Reflux Band in Laryngopharyngeal Reflux
Laryngopharyngeal Reflux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Fernstrom study director
Nexium Global Product Director, AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole and Quality of Life questionnaire in people with Laryngopharyngeal Reflux (LPR), run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2009.