Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma
3 other identifiers
interventional
256
0 countries
N/A
Brief Summary
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Aug 2000
Shorter than P25 for not_applicable asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedResults Posted
Study results publicly available
June 17, 2010
CompletedFebruary 3, 2022
February 1, 2022
6 months
July 21, 2009
July 27, 2009
February 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
1
EXPERIMENTALMontelukast
2
PLACEBO COMPARATORPlacebo
Interventions
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related 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. doi: 10.1185/030079905X48456.
PMID: 15969897RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 22, 2009
Study Start
August 1, 2000
Primary Completion
February 1, 2001
Study Completion
February 1, 2001
Last Updated
February 3, 2022
Results First Posted
June 17, 2010
Record last verified: 2022-02