- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00140881
A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)
February 1, 2022 updated by: Organon and Co
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children
A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
220
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females between the ages of 2 and 14 who have infrequent episodic asthma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission).
|
Secondary Outcome Measures
Outcome Measure |
---|
Parent/caregiver QOL endpoints.
|
The safety and tolerability of montelukast when use as an episode modifier.
|
The duration and severity of the episode assessed by the parent/caregiver symptom score and the use of b-agonist and oral corticosteroid.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2000
Primary Completion (Actual)
February 14, 2003
Study Completion (Actual)
February 14, 2003
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
February 1, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Montelukast
Other Study ID Numbers
- 0476-165
- 2005_055
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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