The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux (ETDLPR)

September 22, 2016 updated by: Loma Linda University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • 11234 Anderson Street
      • Redlands, California, United States, 92374
        • 1895 Orange Tree Lane, Suite 102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: Omeprazole
40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks
Other Names:
  • Prilosec
Drug: Ranitidine
300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks
Other Names:
  • Zantac
Drug: Pantoprazole
40mg, to be taken twice daily by mouth, 30-60 minutes before meals, for at least 6 weeks. (Alternative intervention if participant cannot tolerate omeprazole, is on an anticoagulant medication, or if on medication contraindicated for omeprazole and ranitidine)
Other Names:
  • Protonix
Procedure: 24-Hour Diagnostic pH-Probe Test
Participants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux.
Procedure: Laryngoscopy
Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Helen X Xu, MD, Loma Linda University Otolaryngology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 26, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETDLPR2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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