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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-219 | |||
| 2009_652 |
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This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
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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 | one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinical Adverse Experiences (CAEs) | A clinical 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 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Serious CAEs | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 2 weeks |
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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 |
|---|---|---|---|
| 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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Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime rhinitis symptoms score during the run-in period were excluded from randomization.
Thirty one study sites in the United States.
Prime Therapy Period: Mar-2001 to Jun-2001.
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast 4 mg and 5 mg | Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks. |
| FG001 | Placebo | Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast 4 mg and 5 mg | Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks. |
| BG001 | Placebo |
| 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 Patients With Clinical Adverse Experiences (CAEs) | A clinical 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 during the 2-week, double-blind treatment period were included in the analysis. | Posted | Number | Participants | 2 weeks |
|
During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
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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 | Montelukast 4 mg and 5 mg | Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
Efficacy endpoints are exploratory.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Comparator: Placebo | Drug | one placebo chewable tablet daily at bed time for 2 weeks |
|
| Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | 2 weeks |
| Number of Patients Who Were Discontinued Due to CAEs | 2 weeks |
| Number of Patients With Laboratory Adverse Experiences (LAEs) | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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 | 2 weeks |
| Number of Patients With Serious LAEs | Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 2 weeks |
| Number of Patients With Drug-related LAEs | 2 weeks |
| Number of Patients Who Were Discontinued Due to LAEs | 2 weeks |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. |
|
|
| Secondary | Number of Patients With Serious CAEs | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis. | Posted | Number | Participants | 2 weeks |
|
|
|
| Secondary | Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis. | Posted | Number | Participants | 2 weeks |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to CAEs | All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis. | Posted | Number | Participants | 2 weeks |
|
|
|
| Secondary | Number of Patients With Laboratory Adverse Experiences (LAEs) | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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 during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | 2 weeks |
|
|
|
| Secondary | Number of Patients With Serious LAEs | Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | 2 weeks |
|
|
|
| Secondary | Number of Patients With Drug-related LAEs | All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | 2 weeks |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to LAEs | All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | 2 weeks |
|
|
|
| 1 |
| 280 |
| 73 |
| 280 |
| EG001 | Placebo | Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. | 0 | 133 | 35 | 133 |
| Asthenia/Fatigue | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Body Ache | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Merck CRISP Dict. | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Enuresis | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Facial Edema | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Fever | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Purulent Discharge | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | Merck CRISP Dict. | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | Merck CRISP Dict. | Non-systematic Assessment |
|
| Viral Syndrome | Infections and infestations | Merck CRISP Dict. | Non-systematic Assessment |
|
| Ecchymosis | Cardiac disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Aphthous Stomatitis | Gastrointestinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Epigastric Discomfort | Gastrointestinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Gastric Disorder | Gastrointestinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Allergic Conjunctivitis | Eye disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Blepharitis | Eye disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Conjunctival Edema | Eye disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Conjunctival Injection | Eye disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Epistaxis | Vascular disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Laryngitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Nasal Secretion | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Nasal Turbinate Abnormality | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Ophthalmic Infection | Eye disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Otic Pain | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Otitis | Ear and labyrinth disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Otitis Externa | Ear and labyrinth disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Otitis Media | Ear and labyrinth disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Pharyngitis | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Sinusitis | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Tonsillar Disorder | General disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Shoulder Pain | Musculoskeletal and connective tissue disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Dream Abnormality | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Head Trauma | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Headache | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Hyperkinesia | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Sleep Disorder | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Behavioral Disturbance | Psychiatric disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Eczematous Dermatitis | Skin and subcutaneous tissue disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Excoriation | Skin and subcutaneous tissue disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Keratosis Pilaris | Skin and subcutaneous tissue disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Merck CRISP Dict. | Non-systematic Assessment |
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| Sunburn | Skin and subcutaneous tissue disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Venomous Bite/Sting | Injury, poisoning and procedural complications | Merck CRISP Dict. | Non-systematic Assessment |
|
| Menstrual Disorder | Reproductive system and breast disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Urinary Urgency | Renal and urinary disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Merck CRISP Dict. | Non-systematic Assessment |
|
| Hypercalcemia | Investigations | Merck CRISP Dict. | Non-systematic Assessment |
|
| Hematocrit Decreased | Investigations | Merck CRISP Dict. | Non-systematic Assessment |
|
| Hematocrit Increased | Investigations | Merck CRISP Dict. | Non-systematic Assessment |
|
| Hemoglobin Decreased | Investigations | Merck CRISP Dict. | Non-systematic Assessment |
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| Lymphocytes Decreased | Investigations | Merck CRISP Dict. | Non-systematic Assessment |
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| Mean Corpuscular Volume Increased | Investigations | Merck CRISP Dict. | Non-systematic Assessment |
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| Neutrophils Increased | Investigations | Merck CRISP Dict. | Non-systematic Assessment |
|
| Bone Marrow Depression | Investigations | Merck CRISP Dict. | 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 |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |