Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)
NCT ID: NCT00337675
Last Updated: 2024-05-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1771 participants
INTERVENTIONAL
2006-10-31
2009-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
NCT00289874
A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)
NCT00140881
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
NCT00968201
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
NCT00943683
A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)
NCT00700661
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: drug + episodic supplemental placebo
Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
montelukast sodium
Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
Arm 2: placebo comparator + episodic supplemental drug
Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period
montelukast sodium
Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.
Arm 3: placebo comparator + episodic supplemental placebo
Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
Comparator: Placebo (unspecified)
Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
montelukast sodium
Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
Comparator: Placebo (unspecified)
Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.
montelukast sodium
Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients who have persistent asthma (continual asthma symptoms)
6 Months
5 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Organon and Co
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
Explore related publications, articles, or registry entries linked to this study.
Valovirta E, Boza ML, Robertson CF, Verbruggen N, Smugar SS, Nelsen LM, Knorr BA, Reiss TF, Philip G, Gurner DM. Intermittent or daily montelukast versus placebo for episodic asthma in children. Ann Allergy Asthma Immunol. 2011 Jun;106(6):518-26. doi: 10.1016/j.anai.2011.01.017. Epub 2011 Mar 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK0476-302
Identifier Type: -
Identifier Source: secondary_id
2006_015
Identifier Type: -
Identifier Source: secondary_id
0476-302
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.