A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)
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|ClinicalTrials.gov Identifier: NCT00140881|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : March 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: MK0476; montelukast sodium Drug: Comparator: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children|
|Actual Study Start Date :||June 1, 2000|
|Actual Primary Completion Date :||February 14, 2003|
|Actual Study Completion Date :||February 14, 2003|
- Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission).
- Parent/caregiver QOL endpoints.
- The safety and tolerability of montelukast when use as an episode modifier.
- The duration and severity of the episode assessed by the parent/caregiver symptom score and the use of b-agonist and oral corticosteroid.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140881
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|