Back to results

A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

Primary Purpose

Otitis Media With Effusion

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

lansoprazole

placebo

About this trial

This is an interventional treatment trial for Otitis Media With Effusion focused on measuring otitis media with effusion, gastroesophageal reflux, ear infection, proton pump inhibitor

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

History of chronic otitis media with effusion meeting clinical indications for tympanostomy tubes placement, defined as the presence of middle ear fluid on physical exam for at least 3 months, in at least one ear.

Exclusion Criteria:

Past medical history or concurrent conditions known to increase the incidence of either recurrent otitis media or otitis media with effusion or gastroesophageal reflux disease, including cleft palate, neurological delay, cerebral palsy, Down syndrome, velocardiofacial syndrome, and primary ciliary dyskinesia.
Children with structural abnormalities of the tympanic membranes, such as cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane. These abnormalities would require placement of tympanostomy tubes in standard clinical practice.
Children weighing less than 10 kilograms, due to the lower weight limit for standard Prevacid™ dosing

Sites / Locations

St. Louis Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lansoprazole (Prevacid)

Placebo

Arm Description

Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months

Placebo SoluTab once daily for 2 months

Outcomes

Primary Outcome Measures

Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear

Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar

Secondary Outcome Measures

Acoustic Reflectometry: Level of Risk as Defined by Manufacturer

Spectral gradient acoustic reflectometry is a noninvasive, non-audible acoustic wave used to help detect middle ear fluid. The manufacturer recommends interpretation of the angle result as: <49°, high risk of middle ear effusion (level 5); 49-59°, moderate-high risk (level 4); 60-69°, moderate risk (level 3); 70-95°, low-moderate risk (level 2) and >95°, low risk (level 1).

Number of Participants With Normal Type A Tympanometry

Tympanometry of both ears, coded by Jerger classification (Type A, normal; type B, flat; Type C; negative pressure). This is a standard test of middle ear status as performed by audiologists. Please refer to the reference for more information: Kileny & Zwolan, Diagnostic Audiology, chapter 133, Cummings Otolaryngology-Head and Neck Surgery, Elsevier/Saunders, 2015.

Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire

Questions regarding reflux symptoms, created and evaluated by Nelson et al, Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey, Arch Pediatr Adolesc Med 2000;154;150-154. This study used the GER3-9P version for children aged 3-9 years. Results are reported as number reporting at least one specific symptom in the past week, maximum 7 symptoms.

Full Information

NCT ID

NCT00546117

First Posted

October 17, 2007

Last Updated

May 29, 2018

Sponsor

Washington University School of Medicine

Collaborators

Doris Duke Charitable Foundation, TAP Pharmaceutical Products Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00546117

Brief Title

A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

Official Title

A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington University School of Medicine

Collaborators

Doris Duke Charitable Foundation, TAP Pharmaceutical Products Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.

Detailed Description

This study is being done to see if reflux of stomach fluid might be a cause of fluid in the ears. Earlier studies have found pepsin or pepsinogen, a component of stomach fluid, in the middle ear fluid of many children with chronic middle ear fluid. Anti-reflux medicines called proton pump inhibitors (PPI) reduce the acidity of the contents of the stomach and the activity of pepsin or pepsinogen. We are studying the effectiveness of a PPI called lansoprazole (Prevacid™) in reducing fluid in the ears. If lansoprazole is able to reduce the fluid in the middle ear, this tells us that the reflux of gastric acid into the esophagus and into the ear canal may be causing middle ear fluid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Otitis Media With Effusion

Keywords

otitis media with effusion, gastroesophageal reflux, ear infection, proton pump inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lansoprazole (Prevacid)

Arm Type

Experimental

Arm Description

Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo SoluTab once daily for 2 months

Intervention Type

Drug

Intervention Name(s)

lansoprazole

Other Intervention Name(s)

Prevacid SoluTab

Intervention Description

Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing >30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm.

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

Placebo Solutab

Intervention Description

Placebo Solutab in 15 and 30 mg dosages.

Primary Outcome Measure Information:

Title

Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear

Time Frame

2 months

Title

Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Acoustic Reflectometry: Level of Risk as Defined by Manufacturer

Description

Time Frame

2 months

Title

Number of Participants With Normal Type A Tympanometry

Description

Time Frame

2 months

Title

Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire

Description

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of chronic otitis media with effusion meeting clinical indications for tympanostomy tubes placement, defined as the presence of middle ear fluid on physical exam for at least 3 months, in at least one ear. Exclusion Criteria: Past medical history or concurrent conditions known to increase the incidence of either recurrent otitis media or otitis media with effusion or gastroesophageal reflux disease, including cleft palate, neurological delay, cerebral palsy, Down syndrome, velocardiofacial syndrome, and primary ciliary dyskinesia. Children with structural abnormalities of the tympanic membranes, such as cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane. These abnormalities would require placement of tympanostomy tubes in standard clinical practice. Children weighing less than 10 kilograms, due to the lower weight limit for standard Prevacid™ dosing

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judith EC Lieu, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Louis Children's Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16143181

Citation

Lieu JE, Muthappan PG, Uppaluri R. Association of reflux with otitis media in children. Otolaryngol Head Neck Surg. 2005 Sep;133(3):357-61. doi: 10.1016/j.otohns.2005.05.654.

Results Reference

background

PubMed Identifier

12439157

Citation

Tasker A, Dettmar PW, Panetti M, Koufman JA, P Birchall J, Pearson JP. Is gastric reflux a cause of otitis media with effusion in children? Laryngoscope. 2002 Nov;112(11):1930-4. doi: 10.1097/00005537-200211000-00004.

Results Reference

background

PubMed Identifier

17321879

Citation

Abd El-Fattah AM, Abdul Maksoud GA, Ramadan AS, Abdalla AF, Abdel Aziz MM. Pepsin assay: a marker for reflux in pediatric glue ear. Otolaryngol Head Neck Surg. 2007 Mar;136(3):464-70. doi: 10.1016/j.otohns.2006.08.030.

Results Reference

background

PubMed Identifier

17453471

Citation

Sone M, Yamamuro Y, Hayashi H, Yanagi E, Niwa Y, Nakashima T. Prediction of gastroesophageal reflux in otitis media with effusion in adults. Acta Otolaryngol. 2007 May;127(5):470-3. doi: 10.1080/00016480600868406.

Results Reference

background

Learn more about this trial

A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

We'll reach out to this number within 24 hrs