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

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ClinicalTrials.gov Identifier: NCT00968201
Recruitment Status : Completed
First Posted : August 28, 2009
Results First Posted : August 3, 2010
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: montelukast sodium Drug: Comparator: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 689 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 1997
Actual Primary Completion Date : March 2001
Actual Study Completion Date : March 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study [ Time Frame: 12 weeks of treatment ]
    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 :
  1. Number of Patients With Drug-related CAEs Reported by Patients - Base Study [ Time Frame: 12 weeks of treatment ]
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

  2. Number of Patients With Serious CAEs Reported by Patients - Base Study [ Time Frame: 12 weeks of treatment ]
    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

  3. Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study [ Time Frame: 12 weeks of treatment ]
    Patients who reported serious drug-related CAEs during 12 weeks of treatment

  4. Number of Patients Who Were Discontinued Due to CAEs - Base Study [ Time Frame: 12 weeks of treatment ]
    Patients who were discontinued due to CAEs during 12 weeks of treatment

  5. Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study [ Time Frame: 12 weeks of treatment ]
    Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment

  6. Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study [ Time Frame: 12 weeks of treatment ]
    Patients who were discontinued due to serious CAEs during 12 weeks of treatment

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

  8. Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study [ Time Frame: 12 weeks of treatment ]
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs

  9. Number of Patients Who Were Discontinued Due to LAEs - Base Study [ Time Frame: 12 weeks of treatment ]
    Patients who were discontinued due to LAEs during 12 weeks of treatment

  10. Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study [ Time Frame: 12 weeks of treatment ]
    Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment

  11. Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension [ Time Frame: up to 2.8 years ]
    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

  12. Number of Patients With Drug-related CAEs Reported by Patients - Extension [ Time Frame: up to 2.8 years ]
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

  13. Number of Patients With Serious CAEs Reported by Patients - Extension [ Time Frame: up to 2.8 years ]
    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

  14. Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension [ Time Frame: up to 2.8 years ]

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

    treatment


  15. Number of Patients Who Were Discontinued Due to CAEs - Extension [ Time Frame: up to 2.8 years ]
    Patients who were discontinued due to CAEs up to 2.8 years of treatment

  16. Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension [ Time Frame: up to 2.8 years ]
    Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment

  17. Number of Patients Who Were Discontinued Due to Serious CAEs - Extension [ Time Frame: up to 2.8 years ]
    Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment

  18. Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension [ Time Frame: up to 2.8 years ]
    Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment

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

  20. Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension [ Time Frame: up to 2.8 years ]
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs

  21. Number of Patients With Serious LAEs - Extension [ Time Frame: up to 2.8 years ]
    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

  22. Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension [ Time Frame: up to 2.8 years ]
    Patients who reported serious drug-related LAEs up to 2.8 years of treatment

  23. Number of Patients Who Were Discontinued Due to LAEs - Extension [ Time Frame: up to 2.8 years ]
    Patients who were discontinued due to LAEs up to 2.8 years of treatment

  24. Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension [ Time Frame: up to 2.8 years ]
    Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment

  25. Number of Patients Who Were Discontinued Due to Serious LAEs - Extension [ Time Frame: up to 2.8 years ]
    Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment

  26. Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension [ Time Frame: up to 2.8 years ]
    Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968201


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

Additional Information:
Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00968201     History of Changes
Other Study ID Numbers: 0476-072
2009_651
First Posted: August 28, 2009    Key Record Dates
Results First Posted: August 3, 2010
Last Update Posted: May 12, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action