Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
- Registration Number
- NCT00968201
- Lead Sponsor
- Organon and Co
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 689
- Patient has history of physician diagnosed asthma
- Patient is in otherwise good stable health
- Patient is able to chew a tablet
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 montelukast sodium Montelukast
- Primary Outcome Measures
Name Time Method Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study 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
Name Time Method Number of Patients With Drug-related CAEs Reported by Patients - Base Study 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
Number of Patients With Serious CAEs Reported by Patients - Base Study 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
Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study 12 weeks of treatment Patients who reported serious drug-related CAEs during 12 weeks of treatment
Number of Patients Who Were Discontinued Due to CAEs - Base Study 12 weeks of treatment 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 12 weeks of treatment 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 12 weeks of treatment Patients who were discontinued due to serious CAEs during 12 weeks of treatment
Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study 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
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study 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
Number of Patients Who Were Discontinued Due to LAEs - Base Study 12 weeks of treatment 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 12 weeks of treatment 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 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
Number of Patients With Drug-related CAEs Reported by Patients - Extension 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
Number of Patients With Serious CAEs Reported by Patients - Extension 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
Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension up to 2.8 years Patients who reported serious drug-related CAEs up to 2.8 years of
treatmentNumber of Patients Who Were Discontinued Due to CAEs - Extension up to 2.8 years 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 up to 2.8 years 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 up to 2.8 years 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 up to 2.8 years 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 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
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension 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
Number of Patients With Serious LAEs - Extension 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
Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension up to 2.8 years Patients who reported serious drug-related LAEs up to 2.8 years of treatment
Number of Patients Who Were Discontinued Due to LAEs - Extension up to 2.8 years 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 up to 2.8 years 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 up to 2.8 years 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 up to 2.8 years Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment