A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00968149
First received: August 27, 2009
Last updated: February 27, 2014
Last verified: February 2014
  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 Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968149

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00968149     History of Changes
Other Study ID Numbers: 0476-219, MK0476-219, 2009_652
Study First Received: August 27, 2009
Results First Received: September 15, 2009
Last Updated: February 27, 2014
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 July 20, 2014