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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):
Merck Sharp & Dohme Corp.

Brief Summary:
A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: MK0633 Drug: Comparator: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 688 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma
Study Start Date : January 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
MK0633 10 mg
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
Experimental: 2
MK0633 50 mg
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
Experimental: 3
MK0633 100 mg
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
Placebo Comparator: 4
placebo
Drug: Comparator: placebo
Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks



Primary Outcome Measures :
  1. Pulmonary function test data measured over 6 weeks [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404313


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00404313     History of Changes
Other Study ID Numbers: 0633-007
MK0633-007
2006_553
First Posted: November 28, 2006    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases