Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00289874
First received: February 7, 2006
Last updated: September 10, 2010
Last verified: September 2010
Results First Received: September 9, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: montelukast sodium
Drug: Comparator: 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
One hundred three sites in US; Prime Therapy: March 2006 to July 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who had unresolved symptoms and signs of an upper respiratory tract infection between Visits 1 and 2, or had evidence of active, clinically significant sinus infection within 1 week of Visit 1 or between Visits 1 and 2, or failed to meet minimum requirement for daytime asthma symptoms and daily β-agonist use were excluded.

Reporting Groups
  Description
Montelukast 5 mg Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
Placebo Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.

Participant Flow:   Overall Study
    Montelukast 5 mg     Placebo  
STARTED     203     218  
COMPLETED     197     210  
NOT COMPLETED     6     8  
Adverse Event                 1                 5  
Lost to Follow-up                 1                 1  
Protocol Violation                 3                 2  
Did not meet eligibility                 1                 0  



  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 5 mg Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
Placebo Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
Total Total of all reporting groups

Baseline Measures
    Montelukast 5 mg     Placebo     Total  
Number of Participants  
[units: participants]
  203     218     421  
Age  
[units: years]
Mean ± Standard Deviation
  10.6  ± 2.4     10.7  ± 2.4     10.6  ± 2.4  
Gender  
[units: participants]
     
Female     81     90     171  
Male     122     128     250  
Daily β-agonist use  
[units: Puffs/Day]
Mean ± Standard Deviation
  3.01  ± 1.77     2.72  ± 1.68     2.86  ± 1.73  
Forced expiratory volume in 1 second (FEV1)  
[units: Liters]
Mean ± Standard Deviation
  1.81  ± 0.57     1.84  ± 0.60     1.83  ± 0.58  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3   [ Time Frame: Baseline and week 3 ]

2.  Secondary:   Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period   [ Time Frame: Baseline and Week 3 ]


  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
Safety is reported in the literature.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


Publications:

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00289874     History of Changes
Other Study ID Numbers: 2006_001, MK0476-336
Study First Received: February 7, 2006
Results First Received: September 9, 2009
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration