Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
184 participants
INTERVENTIONAL
2012-04-02
2013-06-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ARRY-502
ARRY-502, CRTh2 antagonist; oral
multiple dose, single schedule
Placebo
Placebo; oral
matching placebo
Interventions
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ARRY-502, CRTh2 antagonist; oral
multiple dose, single schedule
Placebo; oral
matching placebo
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 18 to 35 inclusive.
* An ACQ score of ≥ 1.5 at specified time points prior to first dose of study drug.
* A best prebronchodilator FEV1 of 60% to 85% of the predicted normal value and a change in best postbronchodilator FEV1 of ≥ 12% and ≥ 200 mL at specified time points prior to first dose of study drug.
* Additional criteria exist.
Exclusion Criteria
* Pre-existing lung disease other than asthma.
* Clinically significant dermatologic, hematological, renal, endocrine, pulmonary (other than asthma), gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, musculoskeletal or immunologic disease (excepting allergic disease and asthma) that is uncontrolled despite treatment or is likely in the opinion of the Investigator to require a change in therapy during the study.
* Patients with any current or past history of cancer within 5 years prior to study start except for treated basal cell or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or cervical carcinomas in situ.
* Any history of serious illness requiring hospitalization within 6 months prior to study start.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
* A positive test for drugs or alcohol, unless the positive drug screen is associated with a prescribed medication and is approved by the Medical Monitor.
* Smoking (tobacco or marijuana) within 6 months prior to study start and/or a smoking history of \> 10 packs/year.
* Blood donation of ≥ 1 pint (473 mL) within 8 weeks prior to the first dose of study drug.
* Previous treatment with ARRY-502.
* Additional criteria exist.
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Allergy & Asthma Specialists Medical Group
Huntington Beach, California, United States
Allergy Medical Clinic - Research Division
Los Angeles, California, United States
California Allergy & Asthma Med. Group
Los Angeles, California, United States
Southern California Institute for Respiratory Diseases Inc
Los Angeles, California, United States
Southern California Research
Mission Viejo, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Allergy Associates Medical Group
San Diego, California, United States
Colorado Allergy and Asthma Center
Centennial, Colorado, United States
IMMUNOe International Research Centers
Centennial, Colorado, United States
Asthma & Allergy Associates PC
Colorado Springs, Colorado, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, United States
Pulmonary Disease Specialists
Kissimmee, Florida, United States
South Florida Research Trials
Miami, Florida, United States
Allergy & Asthma Diagnostic Treatment Center
Tallahassee, Florida, United States
Florida Pulmonary Research Institute
Winter Park, Florida, United States
Idaho Research
Eagle, Idaho, United States
Sneeze, Wheeze & Itch
Normal, Illinois, United States
Chesapeake Clinical Research Inc
Baltimore, Maryland, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Clinical Research Institute
Plymouth, Minnesota, United States
Clinical Research Group of Montana
Bozeman, Montana, United States
The Asthma & Allergy Center
Bellevue, Nebraska, United States
Princeton Center for Clinical Research
Skillman, New Jersey, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Allergy, Respiratory & Sleep Center
Canton, Ohio, United States
Bernstein Clinical Research
Cincinnati, Ohio, United States
Toledo Center for Clinical Research
Sylvania, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Allergy Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Baker Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States
University of Pittsburgh Asthma Institute
Pittsburgh, Pennsylvania, United States
Tekton Research
Austin, Texas, United States
Pharmaceutical Research & Consulting Inc.
Dallas, Texas, United States
Western Sky Medical Research Inc
El Paso, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Asthma Inc.
Seattle, Washington, United States
Allergy Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, United States
Asthma Allergy & Pulmonary Research
Madison, Wisconsin, United States
Countries
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Other Identifiers
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C4681001
Identifier Type: OTHER
Identifier Source: secondary_id
ARRAY-502-201
Identifier Type: -
Identifier Source: org_study_id
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