The Safety and Effectiveness of MK0476 in Patients With Chronic Asthma
Information source: Merck
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Comparator: montelukast (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This study will test the safety and effectiveness of a range of doses of MK0476 compared to
placebo on improved lung function in patients with chronic asthma.
Clinical Details
Official title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Compare all active doses to placebo for the average changes in breathing test results (FEV1) comparing results before versus after treatment with MK0476.
Secondary outcome: Compare the average change in FEV1 when a short acting beta-agonist is added to treatment with MK0476 versus treatment with MK0476 alone.
Eligibility
Minimum age: 15 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- A person is 15 to 65 years of age
- A person has had chronic asthma for at least one year
Exclusion Criteria:
- A person is a smoker or has smoked more that a pack a day for more than 10 years
before stopping
- A person has other lung disorders such as COPD (chronic obstructive pulmonary
disorder)
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, North Dartmouth, Massachusetts 02747, United States; Recruiting
Call for Information, St. Louis, Missouri 63141, United States; Recruiting
Call for Information, Omaha, Nebraska 68131-0000, United States; Recruiting
Call for Information, Skillman, New Jersey 08558, United States; Recruiting
Call for Information, Scranton, Pennsylvania 18509, United States; Recruiting
Call for Information, Madison, Wisconsin 53792-9988, United States; Recruiting
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: July 2008
Ending date: January 2009
Last updated: October 22, 2008
|
