The Effect of MK0633 in Patients With Chronic Asthma
A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma...
Brief Summary
Official Title: “A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma”
A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: May 2009
Intervention(s) in this Clinical Trial
- 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
- Drug: Comparator: placebo
- Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- MK0633 10 mg
- Experimental: 2
- MK0633 50 mg
- Experimental: 3
- MK0633 100 mg
- Placebo Comparator: 4
- placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Pulmonary function test data measured over 6 weeks
- Time Frame: 6 weeks
Safety Issue?: No
- Time Frame: 6 weeks
Secondary Measures
- 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
Safety Issue?: No
- Time Frame: 6 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00404313
Study ID Number: 2006_553
ClinicalTrials.gov Identifier: NCT00404313
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00404313
