A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine Doris Duke Charitable Foundation TAP Pharmaceutical Products Inc.
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00546117

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

MedlinePlus related topics: Ear Infections

Drug Information available for: Lansoprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

Primary Outcome Measures:

Resolution of middle ear fluid by pneumatic otoscopy [ Time Frame: 2 months ]

Secondary Outcome Measures:

acoustic reflectometry, tympanometry, reflux symptom questionnaires [ Time Frame: 2 months ]

Estimated Enrollment:	144
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2008

Arms	Assigned Interventions
1: 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.
2: Placebo Comparator Placebo SoluTab 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.

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

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:

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

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.

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.

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.

Study ID Numbers:	HRPO# 07-0762
Study First Received:	October 17, 2007
Last Updated:	October 17, 2007
ClinicalTrials.gov Identifier:	NCT00546117 History of Changes
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

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Proton Pump Inhibitors
Otitis Media with Effusion
Otitis

Otitis Media
Lansoprazole
Ear Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Anti-Infective Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Otitis Media with Effusion
Otitis Media
Gastrointestinal Agents
Enzyme Inhibitors

Ear Diseases
Pharmacologic Actions
Proton Pump Inhibitors
Otitis
Therapeutic Uses
Anti-Ulcer Agents
Lansoprazole

ClinicalTrials.gov processed this record on May 07, 2009