Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
360 participants
INTERVENTIONAL
2000-06-30
2003-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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MK0476, montelukast sodium / Duration of Treatment : 56 Weeks
Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks
Eligibility Criteria
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Inclusion Criteria
* Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty
* With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists)
Exclusion Criteria
6 Years
8 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Becker AB, Kuznetsova O, Vermeulen J, Soto-Quiros ME, Young B, Reiss TF, Dass SB, Knorr BA; Pediatric Montelukast Linear Growth Study Group. Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study. Ann Allergy Asthma Immunol. 2006 Jun;96(6):800-7. doi: 10.1016/s1081-1206(10)61342-7.
Other Identifiers
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2006_550
Identifier Type: -
Identifier Source: secondary_id
0476-097
Identifier Type: -
Identifier Source: org_study_id
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