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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
History of Changes
Results First Received: December 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Otitis Media With Effusion
Interventions: Drug: lansoprazole
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prevacid Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
Placebo Placebo SoluTab once daily for 2 months

Participant Flow:   Overall Study
    Prevacid     Placebo  
STARTED     9     7  
COMPLETED     5     7  
NOT COMPLETED     4     0  
Withdrawal by Subject                 3                 0  
Inability to schedule follow-up visit                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Prevacid Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
Placebo Placebo SoluTab once daily for 2 months
Total Total of all reporting groups

Baseline Measures
    Prevacid     Placebo     Total  
Number of Participants  
[units: participants]
 		  9     7     16  
Age  
[units: participants]
 		     
<=18 years     9     7     16  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  4.82  ± 1.98     5.45  ± 1.32     5.10  ± 1.86  
Gender  
[units: participants]
 		     
Female     5     1     6  
Male     4     6     10  
Region of Enrollment  
[units: participants]
 		     
United States     9     7     16  



  Outcome Measures
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1.  Primary:   Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear   [ Time Frame: 2 months ]
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2.  Primary:   Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar   [ Time Frame: 2 months ]
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3.  Secondary:   Acoustic Reflectometry   [ Time Frame: 2 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Tympanometry   [ Time Frame: 2 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Reflux Symptom Questionnaires   [ Time Frame: 1 and 2 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Judith Lieu, MD
Organization: Washington University
phone: 314-454-6162
e-mail: lieuj@wustl.edu


Publications:


Responsible Party: Judith Lieu, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00546117     History of Changes
Other Study ID Numbers: HRPO# 07-0762
Study First Received: October 17, 2007
Results First Received: December 10, 2010
Last Updated: September 27, 2011
Health Authority: United States: Institutional Review Board