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

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0633
Comparator: placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    MK0633 10 mg

    MK0633 50 mg

    MK0633 100 mg

    placebo

    Outcomes

    Primary Outcome Measures

    Pulmonary function test data measured over 6 weeks

    Secondary Outcome Measures

    Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks

    Full Information

    First Posted
    November 21, 2006
    Last Updated
    October 19, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00404313
    Brief Title
    The Effect of MK0633 in Patients With Chronic Asthma (0633-007)
    Official Title
    A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 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 adult patients with chronic asthma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK0633 10 mg
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    MK0633 50 mg
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    MK0633 100 mg
    Arm Title
    4
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    MK0633
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks
    Primary Outcome Measure Information:
    Title
    Pulmonary function test data measured over 6 weeks
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    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
    21945511
    Citation
    Wasfi YS, Villaran 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.
    Results Reference
    result

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

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