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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-301 | |||
| 2005_026 |
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This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.
The duration of treatment is a one time dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Active Comparator | montelukast sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration | Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. | Baseline and (time weighted average over) 60 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Pulmonary Index [mPI] Score | Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12. The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use. |
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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 |
|---|---|---|---|
| 20306820 | Derived | Morris CR, Becker AB, Pinieiro A, Massaad R, Green SA, Smugar SS, Gurner DM. A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma. Ann Allergy Asthma Immunol. 2010 Feb;104(2):161-71. doi: 10.1016/j.anai.2009.11.065. |
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Phase III World Wide (U.S., Europe, Asia, South America, and Lithuania) Multicenter Study. Study Start Date: July 2005 Primary Completion Date: March 2008 Study Completion Date: March 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast Intravenous (IV) 5.25 mg | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast Intravenous (IV) 5.25 mg | |
| BG001 | Placebo | |
| BG002 | Total |
| 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 | Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration | Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. | Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Baseline and (time weighted average over) 60 Minutes |
|
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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 Intravenous (IV) 5.25 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Infections And Infestations | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Cardiac Disorders | Cardiac disorders | MedDRA 10.1 | 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 | ClinicalTrialsDisclosure@merck.com |
| 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 (unspecified) | Drug | Pbo for a study approximately 120 minutes in duration |
|
| Baseline and 60 minutes |
| Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours) | Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration. | 120 minutes |
| Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration | Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. | Baseline and (time-weighed average over) 45 Minutes |
| Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration | Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. | Baseline and (time-weighted average over) 30 Minutes |
| Change in FEV1 After 15 Minutes Following the End of Study Drug Administration | Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value | Baseline and 15 Minutes |
| Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration | Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration. | 120 minutes |
| Withdrawal by Subject |
|
| Did not meet Inclusion Criteria |
|
| Lack of Efficacy |
|
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity | Number | participants |
|
| Baseline FEV 1 (L) | Forced Expiratory Volume in one second, measured in Liters (FEV 1 (L)) A total of 4/276 (1-montelukast; 3-placebo) randomized patients were excluded from the Full Analysis Set (FAS) of the primary endpoint | Mean | Standard Deviation | Liters |
|
| Baseline FEV1 (Percent predicted) | Percent of predicted baseline Forced Expiratory Volume in one second (FEV1) A total of 4/276 (1-montelukast; 3-placebo) randomized patients were excluded from the Full Analysis Set (FAS) of the primary endpoint | Mean | Standard Deviation | Percent |
|
| Placebo |
|
|
|
| Secondary | Change From Baseline in Modified Pulmonary Index [mPI] Score | Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12. The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use. | Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and 60 minutes |
|
|
|
|
| Secondary | Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours) | Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration. | Full Analysis Set (FAS). At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of treatment failure endpoint. Baseline FEV1 measurement was also required to assess this endpoint since it was included in the model. | Posted | Number | Participants | 120 minutes |
|
|
|
|
| Secondary | Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration | Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. | Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Baseline and (time-weighed average over) 45 Minutes |
|
|
|
|
| Secondary | Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration | Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. | Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Baseline and (time-weighted average over) 30 Minutes |
|
|
|
|
| Secondary | Change in FEV1 After 15 Minutes Following the End of Study Drug Administration | Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value | Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Baseline and 15 Minutes |
|
|
|
|
| Secondary | Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration | Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration. | At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of total doses of Beta-Agonist (mg) endpoint. | Posted | Median | Inter-Quartile Range | mg | 120 minutes |
|
|
|
|
| 2 |
| 20 |
| EG001 | Placebo | 2 | 21 |
| Pneumonia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Injury, Poisoning And Procedural Complications | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Respiratory, Thoracic And Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Asthmatic Crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any General Disorders And Administration Site Conditions | General disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Infusion Site Extravasation | General disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Infusion Site Pain | General disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Infections And Infestations | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Bronchitis Bacterial | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Nervous System Disorders | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Syncope Vasovagal | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Respiratory, Thoracic And Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Skin And Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Vascular Disorders | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Diastolic Hypotension | Vascular disorders | MedDRA 10.1 | 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 |