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

NCT00546117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-06-01

Study results available
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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.

Conditions

  • Otitis Media With Effusion

Interventions

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.

DRUG

placebo

Placebo Solutab in 15 and 30 mg dosages.

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • TAP Pharmaceutical Products Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Judith EC Lieu, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546117 on ClinicalTrials.gov