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MK0476 Study in Adult Patients With Acute Asthma (0476-322)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00229970
First received: September 28, 2005
Last updated: May 27, 2014
Last verified: May 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: MK0476 Phase II/III Placebo Controlled Double Blind Study

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]
    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


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
Experimental: 1
Placebo
Drug: Comparator: Placebo
Placebo single injection
Experimental: 2
MK0476 7 mg injection
Drug: montelukast sodium
7 mg or 14 mg single injection
Experimental: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00229970     History of Changes
Other Study ID Numbers: 0476-322, MK0476-322, 2005_084
Study First Received: September 28, 2005
Results First Received: May 22, 2009
Last Updated: May 27, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014