CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
lansoprazole +1 moredrug
Likely dose
lansoprazole 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00546117
NCT00546117N/ACompleted
CompareCT.gov

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

Washington University School of Medicine·interventional·Posted Oct 18, 2007·Updated Jun 1, 2018

In Brief

A clinical study evaluating lansoprazole and placebo for Otitis Media With Effusion. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media With Effusion
CountriesUnited States
CollaboratorsDoris Duke Charitable Foundation, TAP Pharmaceutical Products Inc.

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2007
Enrollment StartOct 1, 2007
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.7 years ago

Interventions

lansoprazoledrug

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.

placebodrug

Placebo Solutab in 15 and 30 mg dosages.