A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00700661

Purpose

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

Condition	Intervention	Phase
Asthma	Drug: montelukast Drug: placebo (unspecified)	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years

Further study details as provided by Merck:

Primary Outcome Measures:

asthma episodes in 2 - 5 year old children [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the number of treatments and duration of asthma episodes [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Enrollment:	500
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Drug	Drug: montelukast One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks
2: Placebo Comparator Pbo	Drug: placebo (unspecified) Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700661

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Publications:

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_572, MK0476-907
Study First Received:	June 17, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00700661
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Study placed in the following topic categories:

Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009