Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Information source: University of Washington
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Laryngopharyngeal Reflux
Intervention: Dexlansoprazole (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Brant K Oelschlager, MD, Principal Investigator, Affiliation: University of Washington
Overall contact:
Brant K Oelschalger, MD, Phone: 206-543-3518, Email: brant@uw.edu
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.
Clinical Details
Official title: Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole.
Secondary outcome: 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. Laryngoscopic findings pre and post Dexlansoprazole treatment. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Brant K Oelschalger, MD, Phone: 206-543-3518, Email: brant@uw.edu
University of Washington, Seattle, Washington 98105, United States; Not yet recruiting
Brant K Oelschlager, MD, Phone: 206-543-3518, Email: brant@uw.edu
Brant K Oelschlager, MD, Principal Investigator
Additional Information
Starting date: May 2011
Last updated: March 31, 2011
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