Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
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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: NCT00289874 |
Recruitment Status :
Completed
First Posted : February 10, 2006
Results First Posted : October 1, 2010
Last Update Posted : February 17, 2016
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Asthma |
Interventions |
Drug: montelukast sodium Drug: Comparator: Placebo |
Enrollment | 421 |
Participant Flow
Recruitment Details |
One hundred three sites in US; Prime Therapy: March 2006 to July 2007 |
Pre-assignment Details | 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. |
Arm/Group Title | Montelukast 5 mg | Placebo |
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Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks. | Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks. |
Period Title: Overall Study | ||
Started | 203 | 218 |
Completed | 197 | 210 |
Not Completed | 6 | 8 |
Reason Not Completed | ||
Adverse Event | 1 | 5 |
Lost to Follow-up | 1 | 1 |
Protocol Violation | 3 | 2 |
Did not meet eligibility | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Montelukast 5 mg | Placebo | Total | |
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Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks. | Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 203 | 218 | 421 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 203 participants | 218 participants | 421 participants | |
10.6 (2.4) | 10.7 (2.4) | 10.6 (2.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 203 participants | 218 participants | 421 participants | |
Female |
81 39.9%
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90 41.3%
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171 40.6%
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Male |
122 60.1%
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128 58.7%
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250 59.4%
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Daily β-agonist use
Mean (Standard Deviation) Unit of measure: Puffs/Day |
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Number Analyzed | 203 participants | 218 participants | 421 participants | |
3.01 (1.77) | 2.72 (1.68) | 2.86 (1.73) | ||
Forced expiratory volume in 1 second (FEV1)
Mean (Standard Deviation) Unit of measure: Liters |
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Number Analyzed | 203 participants | 218 participants | 421 participants | |
1.81 (0.57) | 1.84 (0.60) | 1.83 (0.58) |
Outcome Measures
Adverse Events
Limitations and Caveats
Safety is reported in the literature.
More Information
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | Senior Vice President, Global Clinical Development |
Organization: | Merck Sharp & Dohme Corp |
Phone: | 1-800-672-6372 |
EMail: | ClinicalTrialsDisclosure@merck.com |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00289874 |
Other Study ID Numbers: |
0476-336 2006_001 |
First Submitted: | February 7, 2006 |
First Posted: | February 10, 2006 |
Results First Submitted: | September 9, 2009 |
Results First Posted: | October 1, 2010 |
Last Update Posted: | February 17, 2016 |