A Study of MK0476 Compared With Placebo in Pediatric Patients With Chronic Asthma
This study has been withdrawn prior to enrollment.
(Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes.)
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00540839
First received: October 4, 2007
Last updated: October 6, 2009
Last verified: October 2009
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Purpose
A study to determine the effects of MK0476 on pediatric patient with chronic asthma compared with placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma, Bronchial |
Drug: montelukast sodium Drug: Comparator: placebo (unspecified) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Improvement of chronic (long-lasting) asthma in children 6 months to 5 years after 24 weeks of treatment with MK0476. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- MK0476 will be safe and well-tolerated in children 6 months to 5 years after 24 weeks of treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2100 |
| Study Start Date: | November 2007 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Arm 1: drug
|
Drug: montelukast sodium
Patients >6 mos to <2 yrs: 4mg packet of oral granules (OG) qd; Patients >2 yrs to <64 mos: 4mg chewable tablet for a 24-wk treatment period.
Other Names:
|
|
Placebo Comparator: 2
Arm 2: Pbo comparator
|
Drug: Comparator: placebo (unspecified)
Patients >6 mos to <2 yrs: 4mg packet of oral granules (OG) Pbo qd; Patients >2 yrs to <64 mos: 4mg chewable tablet Pbo for a 24-wk treatment period.
|
Eligibility| Ages Eligible for Study: | 6 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is between 6 months and 5 years, 4 months of age
- Patient has been diagnosed with asthma by a doctor
- Patient has had at least 3 episodes of asthma symptoms within the last 6 months
Exclusion Criteria:
- Patient has active or chronic breathing disease, other than asthma
- Patient required insertion of a breathing tube for asthma
- Patient had major surgery within the last 4 weeks
- Patient is currently in the hospital
- Patient is allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT00540839 History of Changes |
| Other Study ID Numbers: | 2007_583, MK0476-303 |
| Study First Received: | October 4, 2007 |
| Last Updated: | October 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013