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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00229970
Recruitment Status : Completed
First Posted : September 30, 2005
Results First Posted : July 17, 2009
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 28, 2005
First Posted Date  ICMJE September 30, 2005
Results First Submitted Date  ICMJE May 22, 2009
Results First Posted Date  ICMJE July 17, 2009
Last Update Posted Date May 21, 2015
Study Start Date  ICMJE September 2005
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2010)
The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: baseline over the first 60 minutes ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
To evaluate the improvement of Forced Expiratory Volume in one second (FEV1) from preallocation baseline in acute asthma between intravenous single administration of MK0476 and placebo.
Change History Complete list of historical versions of study NCT00229970 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
No key secondary outcomes.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MK0476 Study in Adult Patients With Acute Asthma (0476-322)
Official Title  ICMJE MK0476 Phase II/III Placebo Controlled Double Blind Study
Brief Summary This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: montelukast sodium
    7 mg or 14 mg single injection
  • Drug: Comparator: Placebo
    Placebo single injection
Study Arms  ICMJE
  • Experimental: 1
    Placebo
    Intervention: Drug: Comparator: Placebo
  • Experimental: 2
    MK0476 7 mg injection
    Intervention: Drug: montelukast sodium
  • Experimental: 3
    MK0476 14 mg injection
    Intervention: Drug: montelukast sodium
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2008)
225
Original Enrollment  ICMJE
 (submitted: September 28, 2005)
240
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number  ICMJE NCT00229970
Other Study ID Numbers  ICMJE 0476-322
MK0476-322
2005_084
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP