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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00551382 |
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Date of registration:
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30/10/2007 |
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Primary sponsor: |
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Public title:
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Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-blind, Placebo-controlled Study
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Scientific title:
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Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00551382 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Israel
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Contacts
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Name:
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Mati Berkovitch, MD |
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Address:
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Telephone:
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972 8 9779152 |
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Email:
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mberkovitch@asaf.health.gov.il |
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Affiliation:
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Name:
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Eran Kozer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assaf-Harofeh Medical Center |
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Name:
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Mati Berkovitch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assaf-Harofeh Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children 1 to 5 years old without significant health problem.
Exclusion Criteria:
- A previous history of wheezing (requiring treatment with bronchodilators in the last
3 month or more than one treatment in the last year)
- Hospital admission due to reactive air way disease
- Prophylactic use of montelukast or steroids
- Chronic cardiac or respiratory disease
- Presence of acute respiratory tract infection within the 7 days before consideration
for the study
- History of allergic Rhinitis
- Children who are receiving chronic medications of any kind
- Known allergy to montelukast
- Inability to get an informed consent from a legal guardian.
Age minimum:
1 Year
Age maximum:
5 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Upper Respiratory Tract Infection
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Intervention(s)
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Drug: Muntelukast
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Drug: Placebo
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Primary Outcome(s)
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The number and duration of URI episodes
[Time Frame: 3 month]
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Secondary Outcome(s)
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Severity of URI episodes,number of days with fever,antibiotic and antipyretic usage, unscheduled visits to physicians office, child's absence from day care or kindergarten, parental absence from work, hospital admissions and adverse reaction of the drug.
[Time Frame: 3 month]
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Secondary ID(s)
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142/06
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20060504(142/06)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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