Laryngo-pharyngeal RefluxNCT01328392
Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
A study testing Dexlansoprazole in people with Laryngo-pharyngeal Reflux, run by University of Washington at 1 site in United States.
Trial summary
Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system which measures liquid reflux in the esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngo-pharyngeal Reflux
- What is being tested?
- Dexlansoprazole
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Apr 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old or above
- Have a clinical diagnosis of LPR
- Able and willing to provide consent
Who cannot join
- History of any previous anti-reflux operation or procedure
- History of pharyngeal or laryngeal surgery
- History of larngeal or hypolaryngeal neoplasm
- Allergy or significant adverse reaction to PPI
- Patient on PPI therapy within 4 weeks prior to enrollment
- A cumulative history of PPI therapy equal to or greater than 3 months
- History of noncompliance with medication or study protocols
- Enrolled in another clinical trial using investigational medications
Trial locations and contacts
1 site in 1 country.
About this study
Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system which measures liquid reflux in the esophagus. The investigators are evaluating a new 24-hour pharyngeal pH monitoring system by Restech which can measure acid exposure in the airway and can be used specifically for LPR diagnosis. The purpose of this study is to determine whether the Restech device is more effective than standard pH monitoring in predicting the response to proton pump inhibitor (PPI) acid suppression therapy using Dexlansoprazole in patients with symptoms and/or manifestations of LPR.
- Conditions
- Laryngo-pharyngeal Reflux
- Being tested
- Dexlansoprazole
- Keywords
- LPR, GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexlansoprazoleDrug
Also called Dexilant
30mg a day, 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole.
Successful LPR symptom improvement will be defined as a 25% improvement in Reflux Symptom Index (RSI)after 3 months of Dexlansoprazole.
Measured: 3 months
Secondary outcomes (5)
Comparison between standard pH data and Restech data (normal vs.abnormal acid exposure, using established normative data values) before and after treatment with Dexlansoprazole.
Measured: 3 months
Correlation between Restech acid exposure events and standard pH monitoring acid exposure events.
Using a method similar to the calculation of a symptom index for each study in each patient, to determine the percentage of time in which a Restech-detected acid event occurs at the same time as an acid event detected on standard pH monitoring.
Measured: 3 months
Laryngoscopic findings pre and post Dexlansoprazole treatment.
Expressed as Reflux Finding Score (RFS).
Measured: 3 months
Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole.
Measured: 3 months
Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Why it stopped: The sponsor did not fund the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngo-pharyngeal RefluxStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Brant K Oelschlager, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328392
- Sponsor's protocol ID
- 39853
- Status last verified
- Mar 2011
- First submitted
- 30 Mar 2011
- Last updated
- 5 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
- ClinicalTrials.gov ID
- NCT01328392
- Acronym / sponsor ID
- 39853
- Conditions
- Laryngo-pharyngeal Reflux
- Keywords
- LPR, GERD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor did not fund the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- May 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 4 Apr 2011 (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.
Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system which measures liquid reflux in the esophagus. The investigators are evaluating a new 24-hour pharyngeal pH monitoring system by Restech which can measure acid exposure in the airway and can be used specifically for LPR diagnosis. The purpose of this study is to determine whether the Restech device is more effective than standard pH monitoring in predicting the response to proton pump inhibitor (PPI) acid suppression therapy using Dexlansoprazole in patients with symptoms and/or manifestations of LPR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years old or above
- Have a clinical diagnosis of LPR
- Able and willing to provide consent
Key exclusion criteria (8 listed)
- History of any previous anti-reflux operation or procedure
- History of pharyngeal or laryngeal surgery
- History of larngeal or hypolaryngeal neoplasm
- Allergy or significant adverse reaction to PPI
- Patient on PPI therapy within 4 weeks prior to enrollment
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 |
|---|---|---|
| DexlansoprazoleAlso: Dexilant30mg a day, 3 months | Drug | – |
Primary outcome
Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole.
Time frame: 3 months
Successful LPR symptom improvement will be defined as a 25% improvement in Reflux Symptom Index (RSI)after 3 months of Dexlansoprazole.
5 secondary outcomes
Comparison between standard pH data and Restech data (normal vs.abnormal acid exposure, using established normative data values) before and after treatment with Dexlansoprazole.
Time frame: 3 months
Correlation between Restech acid exposure events and standard pH monitoring acid exposure events.
Time frame: 3 months
Laryngoscopic findings pre and post Dexlansoprazole treatment.
Time frame: 3 months
Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole.
Time frame: 3 months
Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values.
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
Related trials for Laryngo-pharyngeal Reflux
Enrolling by invitationObservational study
European TIF2.0 Registry
Gastro -Oesophagal Reflux, Laryngo-pharyngeal 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.
Brant K Oelschlager, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexlansoprazole in people with Laryngo-pharyngeal Reflux, run by University of Washington at 1 site in United States.
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole. (time frame: 3 months). 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 5 Jul 2017.