Linear Growth Study - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 2006

Last Updated Date

January 10, 2007

Start Date ^ICMJE

June 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00395408 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Linear Growth Study

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: MK0476, montelukast sodium / Duration of Treatment : 56 Weeks
Drug: Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks

Study Arms / Comparison Groups

Publications *

Becker AB, Kuznetsova O, Vermeulen J, Soto-Quiros ME, Young B, Reiss TF, Dass SB, Knorr BA; Pediatric Montelukast Linear Growth Study Group. Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study. Ann Allergy Asthma Immunol. 2006 Jun;96(6):800-7.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 8 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00395408

Responsible Party

Study ID Numbers ^ICMJE

2006_550

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP