Linear Growth Study (0476-097)(COMPLETED)

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: November 1, 2006
Last updated: May 21, 2013
Last verified: May 2013

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 3

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

Estimated Enrollment: 300
Study Start Date: June 2000
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Years to 8 Years
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
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

Publications: Identifier: NCT00395408     History of Changes
Other Study ID Numbers: 2006_550
Study First Received: November 1, 2006
Last Updated: May 21, 2013
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-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists processed this record on April 17, 2014