The Study of Eustachian Tube Dysfunction and Laryngophary... | NCT02123498

Studies
The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

NCT02123498

Sponsor

Loma Linda University

Status

Withdrawn

Last Update Posted

Sep 26, 2016Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Eustachian Tube Dysfunction
Laryngopharyngeal Reflux

Interventions

Omeprazole
Ranitidine
Pantoprazole
24-Hour Diagnostic pH-Probe Test
Laryngoscopy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IRB not approved

Expanded Access Info

Start Date

Not provided

Primary Completion Date

May 2015Actual

Completion Date

Not provided

First Submitted Date

Apr 23, 2014

First Submission Date that Met QC Criteria

Apr 23, 2014

First Posted Date

Apr 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2016

Last Update Posted Date

Sep 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental		Drug: Omeprazole Drug: Ranitidine Drug: Pantoprazole Procedure: 24-Hour Diagnostic pH-Probe Test Procedure: Laryngoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omeprazole	Drug	40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helen X Xu, MD	Loma Linda University Otolaryngology Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
11234 Anderson Street		Loma Linda	California	92354	United States
1895 Orange Tree Lane, Suite 102

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8834270	Background	Barbero GJ. Gastroesophageal reflux and upper airway disease. Otolaryngol Clin North Am. 1996 Feb;29(1):27-38.
17585281	Background	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.

ID	Term
D057045	Laryngopharyngeal Reflux
D004433	Earache
D005764	Gastroesophageal Reflux

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

ID	Term
D009853	Omeprazole
D011899	Ranitidine
D000077402	Pantoprazole
D007828	Laryngoscopy