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Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Washington.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Takeda Pharmaceuticals North America, Inc.
Restech, Inc
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01328392
First received: March 30, 2011
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  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
Laryngopharyngeal Reflux
 Drug: Dexlansoprazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Correlation between Restech acid exposure events and standard pH monitoring acid exposure events. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Expressed as Reflux Finding Score (RFS).

  • Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328392

Contacts
Contact: Brant K Oelschalger, MD 206-543-3518 brant@uw.edu

Locations
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Brant K Oelschlager, MD     206-543-3518     brant@uw.edu    
Principal Investigator: Brant K Oelschlager, MD            
Sponsors and Collaborators
University of Washington
Takeda Pharmaceuticals North America, Inc.
Restech, Inc
Investigators
Principal Investigator: Brant K Oelschlager, MD University of Washington
  More Information

No publications provided

Responsible Party: Brant Oelschlager, MD, University of Washington
ClinicalTrials.gov Identifier: NCT01328392     History of Changes
Other Study ID Numbers: Takeda IISR
Study First Received: March 30, 2011
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
LPR
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Regurgitation, Gastric
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013