MK0476 Study in Adult Patients With Acute Asthma - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00229970

Purpose

This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

Condition	Intervention	Phase
Asthma	Drug: montelukast sodium Drug: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	MK0476 Phase II/III Placebo Controlled Double Blind Study

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: baseline over the first 60 minutes ] [ Designated as safety issue: No ]

Enrollment:	225
Study Start Date:	September 2005
Study Completion Date:	June 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Placebo	Drug: Comparator: Placebo Placebo single injection
2: Experimental MK0476 7 mg injection	Drug: montelukast sodium 7 mg or 14 mg single injection
3: Experimental MK0476 14 mg injection	Drug: montelukast sodium 7 mg or 14 mg single injection

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult Patients With Acute Asthma Attacks

Exclusion Criteria:

Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)
Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years
Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229970

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_084, MK0476-322
Study First Received:	September 28, 2005
Results First Received:	May 22, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00229970 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions

Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010