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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-322 | |||
| 2005_084 |
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This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Placebo |
|
| 2 | Experimental | MK0476 7 mg injection |
|
| 3 | Experimental | MK0476 14 mg injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | 7 mg or 14 mg single injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) | The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor | baseline over the first 60 minutes |
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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 |
|---|---|---|---|
| 22742205 | Derived | Adachi M, Taniguchi H, Tohda Y, Sano Y, Ishine T, Smugar SS, Hisada S. The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patients. J Asthma. 2012 Aug;49(6):649-56. doi: 10.3109/02770903.2012.690479. Epub 2012 Jun 28. |
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Patients with acute exacerbation of bronchial asthma received standard treatments of inhaled β-agonist or oxygen inhalation to treat the acute exacerbations during the 60 minutes in the screening period before the study randomization.
Phase III.
Studied period: September 12, 2005 (date study drug was first administered to first patient) to October 23, 2006 (date study drug was last administered to last patient). Study was conducted at 64 clinical sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast 7 mg | Montelukast 7 mg Intravenous Administration |
| FG001 | Montelukast 14 mg | Montelukast 14 mg Intravenous Administration |
| FG002 | Placebo | Placebo Intravenous Administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast 7 mg | Montelukast 7 mg Intravenous Administration |
| BG001 | Montelukast 14 mg | Montelukast 14 mg Intravenous Administration |
| 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 | The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) | The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor | Last observed value during the 60 minutes treatment period was used in the Full Analysis Set (FAS) | Posted | Least Squares Mean | 95% Confidence Interval | Liter | baseline over the first 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 7 mg | Montelukast 7 mg Intravenous Administration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood bilirubin increased | Investigations | 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 |
| Drug |
Placebo single injection |
|
| BG002 | Placebo | Placebo Intravenous Administration |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan | Mild (Peak Expiratory Flow: 70%-80%), Moderate (Peak Expiratory Flow: 50%-70%), Severe (Peak Expiratory Flow: <=50%) or Serious (Peak Expiratory Flow: incapable measurement, cyanosis, head trip, disturbed consciousness, incontinence or asphyxia) | Number | participants |
|
| Baseline Forced Expiratory Volume in One Second (FEV1) | Mean | Standard Deviation | Liter |
|
| Duration of Asthma | Mean | Standard Deviation | Years |
|
Montelukast 14 mg Intravenous Administration
| OG002 | Placebo | Placebo Intravenous Administration |
|
|
|
| 2 |
| 23 |
| EG001 | Montelukast 14 mg | Montelukast 14 mg Intravenous Administration | 4 | 11 |
| EG002 | Placebo | Placebo Intravenous Administration | 4 | 13 |
| Acute tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | Non-systematic Assessment |
|
| Blood urine present | Investigations | Non-systematic Assessment |
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| Bronchitis acute | Infections and infestations | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Glucose urine present | Investigations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Protein urine present | Investigations | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | 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 |