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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00546117
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : January 11, 2011
Last Update Posted : October 3, 2011
Sponsor:
Collaborators:
Doris Duke Charitable Foundation
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Judith Lieu, Washington University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Otitis Media With Effusion
Interventions: Drug: lansoprazole
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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

1.  Primary:   Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear   [ Time Frame: 2 months ]

2.  Primary:   Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar   [ Time Frame: 2 months ]

3.  Secondary:   Acoustic Reflectometry   [ Time Frame: 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Tympanometry   [ Time Frame: 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Reflux Symptom Questionnaires   [ Time Frame: 1 and 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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.


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
First Submitted: October 17, 2007
First Posted: October 18, 2007
Results First Submitted: December 10, 2010
Results First Posted: January 11, 2011
Last Update Posted: October 3, 2011