Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Primary Purpose
Laryngo-pharyngeal Reflux
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexlansoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Laryngo-pharyngeal Reflux focused on measuring LPR, GERD
Eligibility Criteria
Inclusion Criteria:
- Age 18 years old or above
- Have a clinical diagnosis of LPR
- Able and willing to provide consent
Exclusion Criteria:
- 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
Sites / Locations
- University of Washington
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Comparison between standard pH data and Restech data (normal vs.abnormal acid exposure, using established normative data values) before and after treatment with Dexlansoprazole.
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.
Laryngoscopic findings pre and post Dexlansoprazole treatment.
Expressed as Reflux Finding Score (RFS).
Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole.
Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values.
Full Information
NCT ID
NCT01328392
First Posted
March 30, 2011
Last Updated
June 30, 2017
Sponsor
University of Washington
Collaborators
Takeda Pharmaceuticals North America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01328392
Brief Title
Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Official Title
Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor did not fund the study.
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
Takeda Pharmaceuticals North America, Inc.
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngo-pharyngeal Reflux
Keywords
LPR, GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole
Other Intervention Name(s)
Dexilant
Intervention Description
30mg a day, 3 months
Primary Outcome Measure Information:
Title
Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole.
Description
Successful LPR symptom improvement will be defined as a 25% improvement in Reflux Symptom Index (RSI)after 3 months of Dexlansoprazole.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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
Title
Correlation between Restech acid exposure events and standard pH monitoring acid exposure events.
Description
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.
Time Frame
3 months
Title
Laryngoscopic findings pre and post Dexlansoprazole treatment.
Description
Expressed as Reflux Finding Score (RFS).
Time Frame
3 months
Title
Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole.
Time Frame
3 months
Title
Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years old or above
Have a clinical diagnosis of LPR
Able and willing to provide consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brant K Oelschlager, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
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Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
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