The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux
NCT ID: NCT02123498
Last Updated: 2016-09-26
Study Results
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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WITHDRAWN
PHASE4
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Omeprazole
40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks
Ranitidine
300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks
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)
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.
Laryngoscopy
Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.
Interventions
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Omeprazole
40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks
Ranitidine
300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks
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)
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.
Laryngoscopy
Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* They are willing to participate in the study.
* They are between the ages of 18 to 80
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Helen X Xu, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University Otolaryngology Department
Locations
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11234 Anderson Street
Loma Linda, California, United States
1895 Orange Tree Lane, Suite 102
Redlands, California, United States
Countries
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References
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Barbero GJ. Gastroesophageal reflux and upper airway disease. Otolaryngol Clin North Am. 1996 Feb;29(1):27-38.
Crapko M, Kerschner JE, Syring M, Johnston N. Role of extra-esophageal reflux in chronic otitis media with effusion. Laryngoscope. 2007 Aug;117(8):1419-23. doi: 10.1097/MLG.0b013e318064f177.
Heavner SB, Hardy SM, White DR, Prazma J, Pillsbury HC 3rd. Transient inflammation and dysfunction of the eustachian tube secondary to multiple exposures of simulated gastroesophageal refluxant. Ann Otol Rhinol Laryngol. 2001 Oct;110(10):928-34. doi: 10.1177/000348940111001007.
Mims JW. The impact of extra-esophageal reflux upon diseases of the upper respiratory tract. Curr Opin Otolaryngol Head Neck Surg. 2008 Jun;16(3):242-6. doi: 10.1097/MOO.0b013e3282fdc3d6.
Norman G, Llewellyn A, Harden M, Coatesworth A, Kimberling D, Schilder A, McDaid C. Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: a health technology assessment. Clin Otolaryngol. 2014 Feb;39(1):6-21. doi: 10.1111/coa.12220.
Schreiber S, Garten D, Sudhoff H. Pathophysiological mechanisms of extraesophageal reflux in otolaryngeal disorders. Eur Arch Otorhinolaryngol. 2009 Jan;266(1):17-24. doi: 10.1007/s00405-008-0770-1. Epub 2008 Aug 13.
Yazici ZM, Sari M, Uneri C, Midi A, Tugtepe H. Histologic changes in eustachian tube mucosa of rats after exposure to gastric reflux. Laryngoscope. 2008 May;118(5):849-53. doi: 10.1097/MLG.0b013e318164d0c0.
Other Identifiers
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ETDLPR2014
Identifier Type: -
Identifier Source: org_study_id
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