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

March 30, 2011
March 31, 2011
May 2011
April 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01328392 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Laryngopharyngeal Reflux
Drug: Dexlansoprazole
30mg a day, 3 months
Other Name: Dexilant
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Brant K Oelschalger, MD 206-543-3518 brant@uw.edu
United States
 
NCT01328392
Takeda IISR
Not Provided
Brant Oelschlager, MD, University of Washington
University of Washington
  • Takeda Pharmaceuticals North America, Inc.
  • Restech, Inc
Principal Investigator: Brant K Oelschlager, MD University of Washington
University of Washington
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP