A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00968149
First received: August 27, 2009
Last updated: April 21, 2010
Last verified: April 2010
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Purpose
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: montelukast sodium Drug: Comparator: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of Patients With Clinical Adverse Experiences (CAEs) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Secondary Outcome Measures:
- Number of Patients With Serious CAEs [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
- Number of Patients With Drug-related CAEs [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
- Number of Patients Who Were Discontinued Due to CAEs [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
- Number of Patients With Laboratory Adverse Experiences (LAEs) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
- Number of Patients With Serious LAEs [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
- Number of Patients With Drug-related LAEs [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
- Number of Patients Who Were Discontinued Due to LAEs [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 413 |
| Study Start Date: | March 2001 |
| Study Completion Date: | July 2001 |
| Primary Completion Date: | June 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Montelukast
|
Drug: montelukast sodium
one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years
|
|
Placebo Comparator: 2
Placebo
|
Drug: Comparator: Placebo
one placebo chewable tablet daily at bed time for 2 weeks
|
Eligibility| Ages Eligible for Study: | 2 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has a history of allergic rhinitis symptoms which flare up during the study season
- Patient is a non-smoker
- Patient is in otherwise good health
- Patient is able to chew a tablet
Exclusion Criteria:
- Patient is hospitalized
- Patient is pregnant or nursing mother, or <8 weeks post partum
- Patient and/or parent intend to move or vacation away from home during the trial
- Patient has had a major surgical procedure within 4 weeks of the prestudy visit
- Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study
- Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study
- Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00968149 History of Changes |
| Other Study ID Numbers: | 2009_652, MK0476-219 |
| Study First Received: | August 27, 2009 |
| Results First Received: | September 15, 2009 |
| Last Updated: | April 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections |
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 June 17, 2013