The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

Phase 4

Withdrawn

• Conditions: Eustachian Tube Dysfunction; Laryngopharyngeal Reflux
• Interventions: Drug: Omeprazole; Drug: Ranitidine; Drug: Pantoprazole; Procedure: 24-Hour Diagnostic pH-Probe Test; Procedure: Laryngoscopy

• Registration Number: NCT02123498
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-25
• Primary Completion: 2015-05
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	24-Hour Diagnostic pH-Probe Test	-
Single Arm	Laryngoscopy	-
Single Arm	Omeprazole	-
Single Arm	Ranitidine	-
Single Arm	Pantoprazole	-

Primary Outcome Measures

Name	Time	Method
Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain	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.

Trial Locations

Locations (2)

1895 Orange Tree Lane, Suite 102; 🇺🇸 Redlands, California, United States

11234 Anderson Street; 🇺🇸 Loma Linda, California, United States