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

October 17, 2007
September 27, 2011
October 2007
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
Resolution of middle ear fluid by pneumatic otoscopy [ Time Frame: 2 months ]
Complete list of historical versions of study NCT00546117 on ClinicalTrials.gov Archive Site
  • 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 ]
acoustic reflectometry, tympanometry, reflux symptom questionnaires [ Time Frame: 2 months ]
Not Provided
Not Provided
 
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Otitis Media With Effusion
  • 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
  • Drug: placebo
    Placebo Solutab in 15 and 30 mg dosages.
    Other Name: Placebo Solutab
  • Experimental: Experimental
    Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
    Intervention: Drug: lansoprazole
  • Placebo Comparator: Placebo
    Placebo SoluTab once daily for 2 months
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
2 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00546117
HRPO# 07-0762
Yes
Judith Lieu, Washington University School of Medicine
Washington University School of Medicine
  • Doris Duke Charitable Foundation
  • TAP Pharmaceutical Products Inc.
Principal Investigator: Judith EC Lieu, MD Washington University School of Medicine
Washington University School of Medicine
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP