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Linear Growth Study (0476-097)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395408
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2000
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. 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 :
  1. To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
  2. Beta-agonist use
  3. Oral corticosteroid rescues for asthma
  4. Discontinuations due to asthma
  5. Peripheral blood eosinophil count
  6. Markers of bone turn-over

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395408

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

Study Data/Documents: CSR Synopsis  This link exits the site

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00395408     History of Changes
Other Study ID Numbers: 0476-097
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Respiratory System Agents
Anti-Asthmatic Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Anti-Inflammatory Agents