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Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

This study has been withdrawn prior to enrollment.
(The sponsor did not fund the study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328392
First Posted: April 4, 2011
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
University of Washington
  Purpose
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.

Condition Intervention
Laryngo-pharyngeal Reflux Drug: Dexlansoprazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


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. [ Time Frame: 3 months ]
  • Correlation between Restech acid exposure events and standard pH monitoring acid exposure events. [ Time Frame: 3 months ]
    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. [ Time Frame: 3 months ]
    Expressed as Reflux Finding Score (RFS).

  • 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 ]

Enrollment: 0
Study Start Date: May 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dexlansoprazole
    30mg a day, 3 months
    Other Name: Dexilant
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328392


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Brant K Oelschlager, MD University of Washington
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01328392     History of Changes
Other Study ID Numbers: 39853
First Submitted: March 30, 2011
First Posted: April 4, 2011
Last Update Posted: July 5, 2017
Last Verified: March 2011

Keywords provided by University of Washington:
LPR
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action