The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Eustachian Tube Dysfunction Laryngopharyngeal Reflux |
| Intervention | Drug: Omeprazole Drug: Ranitidine Drug: Pantoprazole Procedure: 24-Hour Diagnostic pH-Probe Test Procedure: Laryngoscopy |
| Phase | Phase 4 |
| Sponsor | Loma Linda University |
| Responsible Party | Loma Linda University |
| ClinicalTrials.gov Identifier | NCT02123498 |
| First Received | April 23, 2014 |
| Last Updated | April 23, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 23, 2014 |
|---|---|
| Last Updated Date | April 23, 2014 |
| Start Date | April 2014 |
| Estimated Primary Completion Date | May 2015 |
| Current Primary Outcome Measures | Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain [Time Frame: 1 year] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux |
|---|---|
| Official Title | The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR) |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: Omeprazole 40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks Other Names: PrilosecDrug: Ranitidine 300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks Other Names: ZantacDrug: 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: ProtonixProcedure: 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. |
| Study Arm (s) | Experimental: Single Arm |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 100 |
| Estimated Completion Date | May 2015 |
| Estimated Primary Completion Date | May 2015 |
| Eligibility Criteria | 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Helen X Xu, MD (909) 558-2782 hxxu@llu.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02123498 |
|---|---|
| Other Study ID Numbers | ETDLPR2014 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Loma Linda University |
| Study Sponsor | Loma Linda University |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Helen X Xu, MD Loma Linda University Otolaryngology Department |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| 11234 Anderson Street | Loma Linda, California, United States, 92354 Contact: Helen X Xu, MD | 909-558-278224910 | hxxu@llu.eduPrincipal Investigator: Helen X Xu, MD Not yet recruiting |
|---|---|
| 1895 Orange Tree Lane, Suite 102 | Redlands, California, United States, 92374 Contact: Priya Krishna, MD | 909-558-260088558 | pkrishna@llu.eduSub-Investigator: Priya Krishna, MD Not yet recruiting |