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

Loma Linda University (LLU) logo

Loma Linda University (LLU)

Status and phase

Withdrawn
Phase 4

Conditions

Laryngopharyngeal Reflux
Eustachian Tube Dysfunction

Treatments

Drug: Omeprazole
Drug: Ranitidine
Procedure: Laryngoscopy
Procedure: 24-Hour Diagnostic pH-Probe Test
Drug: Pantoprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT02123498
ETDLPR2014

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Single Arm
Experimental group
Treatment:
Drug: Pantoprazole
Procedure: 24-Hour Diagnostic pH-Probe Test
Drug: Ranitidine
Drug: Omeprazole
Procedure: Laryngoscopy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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