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Linear Growth Study (0476-097)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: November 1, 2006
Last updated: September 22, 2015
Last verified: September 2015
The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.

Condition Intervention Phase
Drug: MK0476, montelukast sodium / Duration of Treatment : 56 Weeks
Drug: Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups

Secondary Outcome Measures:
  • To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
  • Beta-agonist use
  • Oral corticosteroid rescues for asthma
  • Discontinuations due to asthma
  • Peripheral blood eosinophil count
  • Markers of bone turn-over

Enrollment: 360
Study Start Date: June 2000
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Years to 8 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria :

  • Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty)
  • 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 :

  • Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00395408

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00395408     History of Changes
Other Study ID Numbers: 0476-097  2006_550 
Study First Received: November 1, 2006
Last Updated: September 22, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones processed this record on October 21, 2016