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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

February 7, 2006
September 10, 2010
March 2006
July 2007   (final data collection date for primary outcome measure)
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 [ Time Frame: Baseline and week 3 ] [ Designated as safety issue: No ]
Percent change from baseline in FEV1, a measure of airway function, at Week 3
Percent change from baseline in Forced Expiratory Volume in 1 minute (FEV1)
Complete list of historical versions of study NCT00289874 on ClinicalTrials.gov Archive Site
Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
Percent change from baseline in average daily β-agonist use over the 3-week treatment period
Percent change from baseline in mean daily "as needed" rescue medication use
Not Provided
Not Provided
 
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity

This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: montelukast sodium
    montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
    Other Name: MK0476
  • Drug: Comparator: Placebo
    Placebo. Up to 3 weeks of treatment
  • Experimental: 1
    montelukast
    Intervention: Drug: montelukast sodium
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Comparator: Placebo
Papadopoulos NG, Philip G, Giezek H, Watkins M, Smugar SS, Polos PG. The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity. J Asthma. 2009 May;46(4):413-20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
421
August 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season
  • Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens

Exclusion Criteria:

  • Patient cannot have any other acute or chronic pulmonary disorder
Both
6 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00289874
2006_001, MK0476-336
Not Provided
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP