An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00132730
First received: August 3, 2005
Last updated: January 26, 2010
Last verified: January 2010

August 3, 2005
January 26, 2010
June 2004
July 2005   (final data collection date for primary outcome measure)
Pre-dose (trough) forced expiratory volume in 1 second measured over the last 4 weeks of a 12 week treatment period [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00132730 on ClinicalTrials.gov Archive Site
  • Overall daytime symptoms score [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Total daily beta-agonist use [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Saint George's Respiratory Questionnaire [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Transitional Dyspnea Rating [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Shortness of Breath Questionnaire [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Chronic Obstructive Pulmonary Disease Exacerbations [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
  • Predose forced vital capacity [ Time Frame: Efficacy at 12 weeks ] [ Designated as safety issue: No ]
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An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0873 in Patients With COPD

This is a study to evaluate the effectiveness and tolerability of a once-daily oral medication for the treatment of COPD (chronic obstructive pulmonary disease) to determine whether the study drug leads to an improvement in pulmonary (lung) function, as well as symptoms, and quality of life.

Following the 12-week active treatment period, patients were invited to continue in an optional 12-week double-blind extension (Period III; MK0873-005-10). Patients who received MK-0873 in the base study continued on 2.5 mg of MK0873 daily while patients in the placebo arm of the base study continued on placebo.

Following Period III, patients were invited to enroll in an optional 28-week, open label extension (Period IV, MK0873-005-20). Patients who had been taking MK-0873 were allocated to 2.5 mg MK0873 + usual care, while patients who had been taking placebo were allocated to usual care alone.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Lung Diseases
  • Pulmonary Disease, Chronic Obstructive
  • Drug: MK0873 2.5 mg
    Period II: MK0873 2.5 mg once daily over 12 weeks
  • Drug: Comparator: MK0873 1.25 mg
    Period II: MK0873 1.25 mg once daily over 12 weeks
  • Drug: Comparator: MK0873 0.75 mg
    Period II: MK0873 0.75 mg once daily over 12 weeks
  • Drug: Comparator: Placebo Comparator
    Period II: Placebo to MK0873 once daily over 12 weeks.
  • Drug: Comparator: Placebo
    Period I: Placebo once daily for one day (run-in)
  • Experimental: Group 1
    Period I: Placebo; Period II: MK0873 2.5 mg
    Interventions:
    • Drug: MK0873 2.5 mg
    • Drug: Comparator: Placebo
  • Experimental: Group 2
    Period I: Placebo; Period II: MK0873 1.25 mg
    Interventions:
    • Drug: Comparator: MK0873 1.25 mg
    • Drug: Comparator: Placebo
  • Experimental: Group 3
    Period I: Placebo; Period II: MK0873 0.75 mg
    Interventions:
    • Drug: Comparator: MK0873 0.75 mg
    • Drug: Comparator: Placebo
  • Placebo Comparator: Group 4
    Period I: Placebo; Period II: Placebo
    Interventions:
    • Drug: Comparator: Placebo Comparator
    • Drug: Comparator: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
604
July 2005
July 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females, 40 to 75 years old, with a history consistent with COPD (chronic obstructive pulmonary disease)
  • Lung function tests that meet the requirements of the study

Exclusion Criteria:

  • Severe and unstable medical conditions other than COPD (chronic obstructive pulmonary disease)
  • Use of continuous oxygen therapy
  • Cardiac (heart) arrhythmias
  • Other lung disease
  • History of colitis (inflammation of the colon)
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00132730
2005_015, MK0873-005
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2010

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