A Study of MK0476 Compared With Placebo in Pediatric Patients With Chronic Asthma

This study has been withdrawn prior to enrollment.

( Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes. )

First Received on October 4, 2007. Last Updated on October 6, 2009 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00540839

Purpose

A study to determine the effects of MK0476 on pediatric patient with chronic asthma compared with placebo.

Condition	Intervention	Phase
Asthma, Bronchial	Drug: montelukast sodium Drug: Comparator: placebo (unspecified)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Improvement of chronic (long-lasting) asthma in children 6 months to 5 years after 24 weeks of treatment with MK0476. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MK0476 will be safe and well-tolerated in children 6 months to 5 years after 24 weeks of treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	2100
Study Start Date:	November 2007
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Arm 1: drug	Drug: montelukast sodium Patients >6 mos to <2 yrs: 4mg packet of oral granules (OG) qd; Patients >2 yrs to <64 mos: 4mg chewable tablet for a 24-wk treatment period. Other Names: MK0476 Singulair®
Placebo Comparator: 2 Arm 2: Pbo comparator	Drug: Comparator: placebo (unspecified) Patients >6 mos to <2 yrs: 4mg packet of oral granules (OG) Pbo qd; Patients >2 yrs to <64 mos: 4mg chewable tablet Pbo for a 24-wk treatment period.

Eligibility

Ages Eligible for Study:	6 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is between 6 months and 5 years, 4 months of age
Patient has been diagnosed with asthma by a doctor
Patient has had at least 3 episodes of asthma symptoms within the last 6 months

Exclusion Criteria:

Patient has active or chronic breathing disease, other than asthma
Patient required insertion of a breathing tube for asthma
Patient had major surgery within the last 4 weeks
Patient is currently in the hospital
Patient is allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540839

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00540839 History of Changes
Other Study ID Numbers:	2007_583, MK0476-303
Study First Received:	October 4, 2007
Last Updated:	October 6, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012