Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

NCT ID: NCT01328392

Last Updated: 2017-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Laryngo-pharyngeal Reflux

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dexlansoprazole

30mg a day, 3 months

Intervention Type DRUG

Other Intervention Names

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Dexilant

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brant K Oelschlager, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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39853

Identifier Type: -

Identifier Source: org_study_id

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