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

This study has been completed.
Sponsor:
Collaborators:
Doris Duke Charitable Foundation
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Judith Lieu, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00546117
First received: October 17, 2007
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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 Intervention
Otitis Media With Effusion
Drug: lansoprazole
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acoustic Reflectometry [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Tympanometry [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Reflux Symptom Questionnaires [ Time Frame: 1 and 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546117

Locations
United States, Missouri
St. Louis Children's Hospital
St. 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
  More Information

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
Study First Received: October 17, 2007
Results First Received: December 10, 2010
Last Updated: September 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Lansoprazole
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014