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The Effect of MK0633 in Patients With Chronic Asthma (0633-007)

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ClinicalTrials.gov Identifier: NCT00404313
Recruitment Status : Terminated
First Posted : November 28, 2006
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):

November 21, 2006
November 28, 2006
October 20, 2015
January 2008
June 2009   (Final data collection date for primary outcome measure)
Pulmonary function test data measured over 6 weeks [ Time Frame: 6 weeks ]
Not Provided
Complete list of historical versions of study NCT00404313 on ClinicalTrials.gov Archive Site
Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks [ Time Frame: 6 weeks ]
Not Provided
Not Provided
Not Provided
 
The Effect of MK0633 in Patients With Chronic Asthma (0633-007)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma
A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: MK0633
    Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633
  • Drug: Comparator: placebo
    Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks
  • Experimental: 1
    MK0633 10 mg
    Intervention: Drug: MK0633
  • Experimental: 2
    MK0633 50 mg
    Intervention: Drug: MK0633
  • Experimental: 3
    MK0633 100 mg
    Intervention: Drug: MK0633
  • Placebo Comparator: 4
    placebo
    Intervention: Drug: Comparator: placebo
Wasfi YS, Villarán C, de Tilleghem Cle B, Smugar SS, Hanley WD, Reiss TF, Knorr BA. The efficacy and tolerability of MK-0633, a 5-lipoxygenase inhibitor, in chronic asthma. Respir Med. 2012 Jan;106(1):34-46. doi: 10.1016/j.rmed.2011.08.019. Epub 2011 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
688
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented clinical history of symptoms of chronic asthma, including dyspnea, wheezing, chest tightness, cough, and/or sputum production
  • Males and females 18-70 years of age

Exclusion Criteria:

  • History of kidney or chronic liver disease
  • Recent history of heart problems within the past 3 months
  • Evidence of another clinically significant, active lung disorder such as bronchiectasis or COPD
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Canada,   Chile,   Colombia,   Ecuador,   Guatemala,   Hungary,   India,   Israel,   Japan,   Malaysia,   Mexico,   New Zealand,   Peru,   Russian Federation,   United States
 
NCT00404313
0633-007
MK0633-007
2006_553
Not Provided
Not Provided
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 2015

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