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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-232 | |||
| 2009_619 |
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Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Montelukast |
|
| 2 | Active Comparator | Usual Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 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 | Up to 52 weeks of treatment |
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Inclusion Criteria:
OR:
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 |
|---|---|---|---|
| 19449366 | Result | Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.21018. |
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This was an open-label, controlled extended safety study. Patients were treated with either montelukast 4-mg oral granules or usual care. Patients who completed Protocol 176-01 had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol 176-01, could also enroll.
Patients were recruited at 27 sites in Africa, Europe, North America, and South America Therapy period: May 2001 to Mar 2003.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks |
| FG001 | Montelukast | Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks |
| BG001 | Montelukast |
| 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 With up to 52 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 | Up to 52 weeks of treatment |
|
Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
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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 | Usual Care | Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial Infection | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial Infection | Infections and infestations | CRISP dictionary | 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: Usual Care | Drug | Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Site terminated and other |
|
Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks. |
|
|
| 1 |
| 32 |
| 30 |
| 32 |
| EG001 | Montelukast | Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks. | 15 | 158 | 155 | 158 |
| Dehydration | Metabolism and nutrition disorders | CRISP dictionary | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Parotitis | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Tonsillar Disorder | General disorders | CRISP dictionary | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Laryngotracheitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Fever | General disorders | CRISP dictionary | Non-systematic Assessment |
|
| Influenza-Like Disease | General disorders | CRISP dictionary | Non-systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | CRISP dictionary | Non-systematic Assessment |
|
| Nasopharyngeal Disorder | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Otitis | Ear and labyrinth disorders | CRISP dictionary | Non-systematic Assessment |
|
| Otitis Media | Ear and labyrinth disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Respiratory Infection | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | CRISP dictionary | Non-systematic Assessment |
|
| Cutaneous Candidiasis | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Eczematous Dermatitis | Skin and subcutaneous tissue disorders | CRISP dictionary | Non-systematic Assessment |
|
| Varicella | Infections and infestations | CRISP dictionary | 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 |