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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Doris Duke Charitable Foundation; TAP Pharmaceutical Products Inc.
• Treatments: Dexlansoprazole; Lansoprazole; Proton Pump Inhibitors

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