Eustachian Tube DysfunctionPhase 4ETDLPRNCT02123498
The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux
A Phase 4 study testing Omeprazole, Ranitidine and Pantoprazole in people with Eustachian Tube Dysfunction and Laryngopharyngeal Reflux, run by Loma Linda University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eustachian Tube Dysfunction, Laryngopharyngeal Reflux
- What is being tested?
- Omeprazole, Ranitidine and Pantoprazole
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento May 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
11234 Anderson Street
Loma Linda, California, 92354
1895 Orange Tree Lane, Suite 102
Redlands, California, 92374
About this study
Official title: 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.
- Being tested
- Omeprazole, Ranitidine, Pantoprazole, 24-Hour Diagnostic pH-Probe Test, Laryngoscopy
- Keywords
- ear pressure, ear fullness, ear pain, ETD, laryngopharyngeal reflux, LPR, gastroesophageal reflux disease, GERD, nasopharyngeal reflux, acid reflux
- Medical subject headings
- Laryngopharyngeal Reflux, Earache, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Prilosec
40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks
RanitidineDrug
Also called Zantac
300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks
PantoprazoleDrug
Also called Protonix
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 TestProcedure or surgery
Participants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux.
LaryngoscopyProcedure or surgery
Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: Omeprazole; Drug: Ranitidine; Drug: Pantoprazole; Procedure: 24-Hour Diagnostic pH-Probe Test; Procedure: Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Primary completionMay 2015
Why it stopped: IRB not approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen X Xu, MD, Principal investigator, Loma Linda University Otolaryngology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123498
- Sponsor's protocol ID
- ETDLPR2014
- Acronym
- ETDLPR
- Status last verified
- Apr 2014
- First submitted
- 23 Apr 2014
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barbero GJ. Gastroesophageal reflux and upper airway disease. Otolaryngol Clin North Am. 1996 Feb;29(1):27-38.
PubMed 8834270Crapko 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.
PubMed 17585281Heavner 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.
PubMed 11642425Mims 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.
PubMed 18475079Norman 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.
PubMed 24438176Schreiber 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.
PubMed 18704479Yazici 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.
PubMed 18300701
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR)
- ClinicalTrials.gov ID
- NCT02123498
- Acronym / sponsor ID
- ETDLPR / ETDLPR2014
- Keywords
- ear pressure, ear fullness, ear pain, ETD, laryngopharyngeal reflux, LPR, gastroesophageal reflux disease, GERD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB not approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Primary completion
- May 2015 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Omeprazole, Drug: Ranitidine, Drug: Pantoprazole, Procedure: 24-Hour Diagnostic pH-Probe Test, Procedure: Laryngoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: Prilosec40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks | Drug | Single Arm |
| RanitidineAlso: Zantac300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks | Drug | Single Arm |
| PantoprazoleAlso: Protonix40mg, 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) | Drug | Single Arm |
| 24-Hour Diagnostic pH-Probe TestParticipants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux. | Procedure or surgery | Single Arm |
| LaryngoscopyParticipants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux. | Procedure or surgery | Single Arm |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Background: PubMed 8834270Barbero GJ. Gastroesophageal reflux and upper airway disease. Otolaryngol Clin North Am. 1996 Feb;29(1):27-38.
- Background: PubMed 17585281Crapko 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.
- Background: PubMed 11642425Heavner 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.
- Background: PubMed 18475079Mims 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.
- Background: PubMed 24438176Norman 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.
- Background: PubMed 18704479Schreiber 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.
- Background: PubMed 18300701Yazici 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen X Xu, MD principal investigator
Loma Linda University Otolaryngology Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole, Ranitidine and Pantoprazole in people with Eustachian Tube Dysfunction and Laryngopharyngeal Reflux, run by Loma Linda University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123498, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.