Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

• Status: Withdrawn
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Restech, Inc; Takeda Pharmaceuticals North America, Inc.
• Treatments: Dexlansoprazole; Lansoprazole

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