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A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
David Skoner, MD, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00189462
First received: September 13, 2005
Last updated: October 13, 2014
Last verified: October 2014
Results First Received: September 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Acute Otitis Media
Otitis Media
Ear Infection
Intervention: Drug: Montelukast

  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
Montelukast

Treatment with montelukast for 4 months (4 mg per day)

Montelukast

Placebo Treatment with placebo for 4 months

Participant Flow:   Overall Study
    Montelukast   Placebo
STARTED   50   49 
COMPLETED   27   28 
NOT COMPLETED   23   21 
Lack of Efficacy                5                1 
Lost to Follow-up                18                20 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Montelukast

Treatment with montelukast for 4 months (4 mg per day)

Montelukast

Placebo Treatment with placebo for 4 months
Total Total of all reporting groups

Baseline Measures
   Montelukast   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   49   99 
Age 
[Units: Participants]
     
<=18 years   50   49   99 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   24   20   44 
Male   26   29   55 
Region of Enrollment [1] 
[Units: Participants]
     
United States   50   49   99 
[1] All subjects were enrolled in the Pittsburgh area


  Outcome Measures

1.  Primary:   Incidence of Acute Otitis Media   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: David Skoner, MD
Organization: West Penn Allegheny Health System
phone: 4123594099
e-mail: dskoner@wpahs.org



Responsible Party: David Skoner, MD, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00189462     History of Changes
Other Study ID Numbers: RC - 3643
Study First Received: September 13, 2005
Results First Received: September 23, 2014
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board