Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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
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.
No text entered.

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  
Number of Participants  
[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


No publications provided


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