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

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ClinicalTrials.gov Identifier: NCT00546117
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : January 11, 2011
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
Doris Duke Charitable Foundation
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Judith Lieu, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Drug: lansoprazole Drug: placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
Study Start Date : October 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: Lansoprazole (Prevacid)
Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
Drug: lansoprazole
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.
Other Name: Prevacid SoluTab

Placebo Comparator: Placebo
Placebo SoluTab once daily for 2 months
Drug: placebo
Placebo Solutab in 15 and 30 mg dosages.
Other Name: Placebo Solutab




Primary Outcome Measures :
  1. Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear [ Time Frame: 2 months ]
  2. Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Acoustic Reflectometry: Level of Risk as Defined by Manufacturer [ Time Frame: 2 months ]
    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).

  2. Number of Participants With Normal Type A Tympanometry [ Time Frame: 2 months ]

    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.


  3. Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire [ Time Frame: 2 months ]
    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.



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546117


Locations
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Doris Duke Charitable Foundation
TAP Pharmaceutical Products Inc.
Investigators
Principal Investigator: Judith EC Lieu, MD Washington University School of Medicine

Publications:
Responsible Party: Judith Lieu, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00546117     History of Changes
Other Study ID Numbers: HRPO# 07-0762
First Posted: October 18, 2007    Key Record Dates
Results First Posted: January 11, 2011
Last Update Posted: June 1, 2018
Last Verified: May 2018

Keywords provided by Judith Lieu, Washington University School of Medicine:
otitis media with effusion
gastroesophageal reflux
ear infection
proton pump inhibitor

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases
Proton Pump Inhibitors
Lansoprazole
Dexlansoprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents