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Completed

NCT Number: NCT00968201

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks

Comparator: placebo

Drug

one chewable placebo tablet, once daily at bedtime for 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2001
Study completion
2001
First posted
Aug 28, 2009
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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