Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)

Asthma Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943683
• Other study ID #: 0476-176
• Secondary ID: MK0476-1762009_6
• Status: Completed
• Phase: N/A
• Start date: August 2000
• Est. completion date: February 2001

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: February 2001
• Est. primary completion date: February 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

• Patient is in good, stable health

• Patient has been fed solid foods for at least 1 month

• Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit

• Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

• Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• montelukast sodium
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
• Comparator: Placebo
Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

van Adelsberg J, Moy J, Wei LX, Tozzi CA, Knorr B, Reiss TF. Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma. Curr Med Res Opin. 2005 Jun;21(6):971-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-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	During the 6 weeks of treatment