Study of an Approved Drug and Its Effect on Growth in Children (0476-254)(COMPLETED)

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: September 21, 2004
Last updated: May 21, 2013
Last verified: May 2013

The purpose of this study is to determine the effect of an approved medication on the lower leg growth rate in children with mild asthma.

Condition Intervention Phase
Asthma, Bronchial
Drug: MK0476, montelukast sodium
Drug: Comparators: montelukast, placebo, and budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 2-Arm, 2X2 Crossover Study Comparing the Effects of Montelukast, Inhaled Budesonide, and Placebo on Lower Leg Growth in Children (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:
  • Growth rate of the lower leg length over the 3-week treatment period

Estimated Enrollment: 72
Study Start Date: October 2002
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 3 weeks.


Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A 6-month history of asthma with periodic episodes requiring treatment.

Exclusion Criteria:

  • Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
  Contacts and Locations
Please refer to this study by its identifier: NCT00092092

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

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp Identifier: NCT00092092     History of Changes
Other Study ID Numbers: 2004_023, MK0476-254
Study First Received: September 21, 2004
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Leukotriene Antagonists
Hormone Antagonists processed this record on April 16, 2014