Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00968201
First received: August 27, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.


Condition Intervention Phase
Asthma
Drug: montelukast sodium
Drug: Comparator: Placebo
Phase 3

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, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients

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 (CAE) Reported by Patients - Base Study [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    An 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 Drug-related CAEs Reported by Patients - Base Study [ Time Frame: 12 weeks of treatment ] [ 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 With Serious CAEs Reported by Patients - Base Study [ Time Frame: 12 weeks of treatment ] [ 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 Serious Drug-related CAEs Reported by Patients - Base Study [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Patients who reported serious drug-related CAEs during 12 weeks of treatment

  • Number of Patients Who Were Discontinued Due to CAEs - Base Study [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to CAEs during 12 weeks of treatment

  • Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment

  • Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to serious CAEs during 12 weeks of treatment

  • Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study [ Time Frame: 12 weeks of treatment ] [ 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 Drug-related Laboratory Adverse Experiences (LAEs) - Base Study [ Time Frame: 12 weeks of treatment ] [ 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) LAEs

  • Number of Patients Who Were Discontinued Due to LAEs - Base Study [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to LAEs during 12 weeks of treatment

  • Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment

  • Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    An 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

  • Number of Patients With Drug-related CAEs Reported by Patients - Extension [ Time Frame: up to 2.8 years ] [ 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 With Serious CAEs Reported by Patients - Extension [ Time Frame: up to 2.8 years ] [ 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 Serious Drug-related CAEs Reported by Patients - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]

    Patients who reported serious drug-related CAEs up to 2.8 years of

    treatment


  • Number of Patients Who Were Discontinued Due to CAEs - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to CAEs up to 2.8 years of treatment

  • Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment

  • Number of Patients Who Were Discontinued Due to Serious CAEs - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment

  • Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment

  • Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension [ Time Frame: up to 2.8 years ] [ 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 Drug-related Laboratory Adverse Experiences (LAEs) - Extension [ Time Frame: up to 2.8 years ] [ 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) LAEs

  • Number of Patients With Serious LAEs - Extension [ Time Frame: up to 2.8 years ] [ 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 Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    Patients who reported serious drug-related LAEs up to 2.8 years of treatment

  • Number of Patients Who Were Discontinued Due to LAEs - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to LAEs up to 2.8 years of treatment

  • Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment

  • Number of Patients Who Were Discontinued Due to Serious LAEs - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment

  • Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension [ Time Frame: up to 2.8 years ] [ Designated as safety issue: Yes ]
    Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment


Enrollment: 689
Study Start Date: December 1997
Study Completion Date: March 2001
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Montelukast
Drug: montelukast sodium
one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks
Placebo Comparator: 2
Placebo
Drug: Comparator: Placebo
one chewable placebo tablet, once daily at bedtime for 12 weeks

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has history of physician diagnosed asthma
  • Patient is in otherwise good stable health
  • Patient is able to chew a tablet

Exclusion Criteria:

  • Patient is hospitalized
  • Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
  • Patient had any major surgical procedure within 4 weeks before the study
  • Patient had active sinus disease within 3 weeks before the study
  • Patient had required intubation for asthma in the past
  • Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study
  • Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968201

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: NCT00968201     History of Changes
Other Study ID Numbers: 0476-072, 2009_651
Study First Received: August 27, 2009
Results First Received: September 15, 2009
Last Updated: March 6, 2014
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 April 17, 2014