The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR)

Loma Linda University2 sites in 1 countryApril 25, 2014

ConditionsEustachian Tube Dysfunction Laryngopharyngeal Reflux

InterventionsOmeprazole Ranitidine Pantoprazole 24-Hour Diagnostic pH-Probe Test Laryngoscopy

DrugsOmeprazole Ranitidine Pantoprazole

Overview

Phase: Phase 4
Intervention: Omeprazole
Conditions: Eustachian Tube Dysfunction
Sponsor: Loma Linda University
Locations: 2
Primary Endpoint: Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the relationship between ear fullness, pressure, and/or pain and laryngopharyngeal reflux, in order to focus medical therapy and improve therapeutic outcomes in this patient population.

Registry

clinicaltrials.gov

Start Date

April 25, 2014

End Date

May 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Loma Linda University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•They complain of symptoms of ear fullness, ear pain, and/or ear pressure, either unilateral or bilateral
•They are willing to participate in the study.
•They are between the ages of 18 to 80

Exclusion Criteria

•They have had major ear surgery (not including tympanostomy tubes)
•They have a medical condition that is another possible etiology of ear pain or acid reflux and may require additional medical or surgical intervention such as: Acute or chronic otitis externa, Chronic otitis media, Temporomandibular joint dysfunction, Upper aerodigestive track neoplasm, History of head/neck radiation therapy.
•They are pregnant. Proton pump inhibitors are a Category C drug with unknown pregnancy risks.
•They do not wish to participate in the study
•They are \<18 or \>80.

Arms & Interventions

Single Arm

Intervention: Omeprazole

Single Arm

Intervention: Ranitidine

Single Arm

Intervention: Pantoprazole

Single Arm

Intervention: 24-Hour Diagnostic pH-Probe Test

Single Arm

Intervention: Laryngoscopy

Outcomes

Primary Outcomes

Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain

Time Frame: 1 year

Participants complaining of ear pain, ear fullness, or ear pain are diagnosed with laryngopharyngeal reflux via laryngoscope exam and measurement by diagnostic pH-probe test.