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Trial record 6 of 6 for:    mk0633

A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)

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: NCT00418613
Recruitment Status : Completed
First Posted : January 5, 2007
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE January 3, 2007
First Posted Date  ICMJE January 5, 2007
Last Update Posted Date September 3, 2015
Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
Pulmonary function test data [ Time Frame: Measured over 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2007)
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Change History Complete list of historical versions of study NCT00418613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2008)
Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score [ Time Frame: Measured over 12 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2007)
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions of MK0633 in Patients With COPD
Brief Summary A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: MK633
    MK0633 100mg capsules qd for a 12-wk treatment period.
  • Drug: Comparator: Placebo (unspecified)
    MK0633 100mg Pbo capsules for a 12-wk treatment period
Study Arms  ICMJE
  • Experimental: 1
    MK0633
    Intervention: Drug: MK633
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Comparator: Placebo (unspecified)
Publications * Bernstein JA, Liu N, Knorr BA, Smugar SS, Hanley WD, Reiss TF, Greenberg S. MK-0633, a potent 5-lipoxygenase inhibitor, in chronic obstructive pulmonary disease. Respir Med. 2011 Mar;105(3):392-401. doi: 10.1016/j.rmed.2010.09.021. Epub 2010 Nov 13.

*   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: May 1, 2009)
266
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented COPD defined by clinical history and spirometry, with symptoms including dyspnea, wheezing, chest tightness, cough, sputum production, or nocturnal awakening
  • Male or postmenopausal females 40 -75 years of age

Exclusion Criteria:

  • Impaired renal function
  • History of chronic liver disease or persistent liver function test (LFT) abnormalities
  • History of recent cardiovascular clinical event
  • Evidence of another clinically significant, active pulmonary disorder such as bronchiectasis or asthma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (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 Canada,   Chile,   Colombia,   Israel,   Japan,   Lithuania,   Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT00418613
Other Study ID Numbers  ICMJE 0633-009
MK0633-009
2006_509
Has Data Monitoring Committee Not Provided
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 September 2015

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