Study of an Approved Drug and Its Effect on Growth in Children - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092092

Purpose

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: monkelukast, placebo, and budesonide	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Growth rate of the lower leg length over the 3-week treatment period

Estimated Enrollment:	72
Study Start Date:	October 2002

Detailed Description:

The duration of treatment is 3 weeks.

Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00092092

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Pedersen S, Agertoft L, Williams-Herman D, Kuznetsova O, Reiss TF, Knorr B, Dass SB, Wolthers OD. Placebo-controlled study of montelukast and budesonide on short-term growth in prepubertal asthmatic children. Pediatr Pulmonol. 2007 Sep;42(9):838-43.

Study ID Numbers:	2004_023
Study First Received:	September 21, 2004
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00092092
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Budesonide
Hypersensitivity, Immediate
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009