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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK633
Comparator: Placebo (unspecified)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    MK0633

    Placebo

    Outcomes

    Primary Outcome Measures

    Pulmonary function test data

    Secondary Outcome Measures

    Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score

    Full Information

    First Posted
    January 3, 2007
    Last Updated
    September 2, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00418613
    Brief Title
    A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions of MK0633 in Patients With COPD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic Obstructive Pulmonary Disease (COPD).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease (COPD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    266 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK0633
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    MK633
    Intervention Description
    MK0633 100mg capsules qd for a 12-wk treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo (unspecified)
    Intervention Description
    MK0633 100mg Pbo capsules for a 12-wk treatment period
    Primary Outcome Measure Information:
    Title
    Pulmonary function test data
    Time Frame
    Measured over 12 weeks
    Secondary Outcome Measure Information:
    Title
    Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score
    Time Frame
    Measured over 12 weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20970976
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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