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MK0524 Asthma POC Study (0524-008)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00783601
First received: October 30, 2008
Last updated: October 27, 2014
Last verified: October 2014

October 30, 2008
October 27, 2014
October 2004
May 2005   (final data collection date for primary outcome measure)
To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Last 2 weeks of each treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00783601 on ClinicalTrials.gov Archive Site
To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores [ Time Frame: Last 2 weeks of each treatment period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MK0524 Asthma POC Study (0524-008)(COMPLETED)
A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma

The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: Comparator: MK0524 + placebo
    Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks
  • Drug: Comparator: MK0524 + montelukast
    Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks
  • Drug: Comparator: placebo + montelukast
    Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks
  • Drug: Comparator: Placebo
    During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.
  • Experimental: 1
    Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast
    Interventions:
    • Drug: Comparator: MK0524 + placebo
    • Drug: Comparator: MK0524 + montelukast
    • Drug: Comparator: placebo + montelukast
    • Drug: Comparator: Placebo
  • Experimental: 2
    Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast
    Interventions:
    • Drug: Comparator: MK0524 + placebo
    • Drug: Comparator: MK0524 + montelukast
    • Drug: Comparator: placebo + montelukast
    • Drug: Comparator: Placebo
Philip G, van Adelsberg J, Loeys T, Liu N, Wong P, Lai E, Dass SB, Reiss TF. Clinical studies of the DP1 antagonist laropiprant in asthma and allergic rhinitis. J Allergy Clin Immunol. 2009 Nov;124(5):942-8.e1-9. Epub 2009 Sep 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
May 2005
May 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year
  • Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years)

Exclusion Criteria:

  • Any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure
  • Any surgery within 4 weeks prior to Visit 1
  • Patient is intending to move or vacation for more than 5 days during the study
  • Patient is pregnant or breast-feeding
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00783601
0524-008, MK0524-008, 2007_614
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2014

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