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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00337675 |
Purpose
This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: montelukast sodium Drug: Comparator: Placebo (unspecified) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years |
| Enrollment: | 1771 |
| Study Start Date: | October 2006 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1: drug + episodic supplemental placebo
Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
|
Drug: montelukast sodium
Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
Other Names:
|
|
Active Comparator: Arm 2: placebo comparator + episodic supplemental drug
Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period
|
Drug: montelukast sodium
Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.
Other Names:
|
|
Placebo Comparator: Arm 3: placebo comparator + episodic supplemental placebo
Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
|
Drug: Comparator: Placebo (unspecified)
Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.
|
Eligibility| Ages Eligible for Study: | 6 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00337675 History of Changes |
| Other Study ID Numbers: | 2006_015, MK0476-302 |
| Study First Received: | June 14, 2006 |
| Results First Received: | February 19, 2010 |
| Last Updated: | April 20, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |