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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-176 | |||
| 2009_618 |
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A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Montelukast |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15969897 | Result | 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. |
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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
Patients were recruited at 65 study centers in Africa, Asia, Europe, North America, and South America Therapy period: Aug 2000 to Feb 2001
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks |
| FG001 | Montelukast | Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks |
| BG001 | Montelukast | Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All patients who took study medication were included in the analysis. | Posted | Number | Participants | During the 6 weeks of treatment |
|
During the 6 weeks of treatment and including 14 days following treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | CRISP dictionaries | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | CRISP dictionaries | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Comparator: Placebo | Drug | Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks |
|
| Protocol Violation |
|
| Withdrawal by Subject |
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| Patient Moved |
|
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
|
| 1 |
| 81 |
| 55 |
| 81 |
| EG001 | Montelukast | Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks | 7 | 175 | 112 | 175 |
| Drug Overdose | Injury, poisoning and procedural complications | CRISP dictionaries | Non-systematic Assessment |
|
| Inguinal Hernia | Musculoskeletal and connective tissue disorders | CRISP dictionaries | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CRISP dictionaries | Non-systematic Assessment |
|
| Aspiration (Condition) | Respiratory, thoracic and mediastinal disorders | CRISP dictionaries | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | CRISP dictionaries | Non-systematic Assessment |
|
| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionaries | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | CRISP dictionaries | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CRISP dictionaries | Non-systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | CRISP dictionaries | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CRISP dictionaries | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CRISP dictionaries | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | CRISP dictionaries | Non-systematic Assessment |
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| Otitis Media | Ear and labyrinth disorders | CRISP dictionaries | Non-systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionaries | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | CRISP dictionaries | Non-systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionaries | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CRISP dictionaries | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |