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Brief Title: Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy
Official Title: A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects With Head and Neck Cancer (HNC)
Study ID: NCT02542215
Brief Summary: Treatment for head and neck cancer often involves a combination of chemotherapy and radiation. One of the unfortunate consequences of standard care for head and neck cancer is the development of painful mouth sores, known as oral mucositis. This study will evaluate the use of cobiprostone spray to prevent oral mucositis, when given for the duration of radiation and chemotherapy (RT/CT) standard care.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Investigational Site, Birmingham, Alabama, United States
Investigational Site, Peoria, Arizona, United States
Investigational Site, Yuma, Arizona, United States
Investigational Site, Little Rock, Arkansas, United States
Investigational Site, Duarte, California, United States
Investigational Site, Fullerton, California, United States
Investigational Site, Los Angeles, California, United States
Investigational Site, Montebello, California, United States
Investigational Site, Oceanside, California, United States
Investigational Site, Redondo Beach, California, United States
Investigational Site, San Francisco, California, United States
Investigational Site, Whittier, California, United States
Investigational Site, Denver, Colorado, United States
Investigational Site, Farmington, Connecticut, United States
Investigational Site, Fort Lauderdale, Florida, United States
Investigational Site, Fort Myers, Florida, United States
Investigational Site, Lakeland, Florida, United States
Investigational Site, Miami Beach, Florida, United States
Investigational Site, Naples, Florida, United States
Investigational Site, Plantation, Florida, United States
Investigational Site, Stuart, Florida, United States
Investigational Site, Winter Haven, Florida, United States
Investigational Site, Boise, Idaho, United States
Investigational Site, Urbana, Illinois, United States
Investigational Site, Fort Wayne, Indiana, United States
Investigational Site, South Bend, Indiana, United States
Investigational Site, Topeka, Kansas, United States
Investigational Site, Ashland, Kentucky, United States
Investigational Site, Baton Rouge, Louisiana, United States
Investigational Site, Metairie, Louisiana, United States
Investigational Site, New Orleans, Louisiana, United States
Investigational Site, Shreveport, Louisiana, United States
Investigational Site, Baltimore, Maryland, United States
Investigational Site, Bethesda, Maryland, United States
Investigational Site, Burlington, Massachusetts, United States
Investigational Site, Ann Arbor, Michigan, United States
Investigational Site, Detroit, Michigan, United States
Investigational Site, East Lansing, Michigan, United States
Investigational Site, Minneapolis, Minnesota, United States
Investigational Site, Saint Louis, Missouri, United States
Investigational Site, Billings, Montana, United States
Investigational Site, Omaha, Nebraska, United States
Investigational Site, Reno, Nevada, United States
Investigational Site, Egg Harbor Township, New Jersey, United States
Investigational Site, New Brunswick, New Jersey, United States
Investigational Site, Charlotte, North Carolina, United States
Investigational Site, Gastonia, North Carolina, United States
Investigational Site, Greenville, North Carolina, United States
Investigational Site, Canton, Ohio, United States
Investigational Site, Sylvania, Ohio, United States
Investigational Site, Oklahoma City, Oklahoma, United States
Investigational Site, Coos Bay, Oregon, United States
Investigational Site, Corvallis, Oregon, United States
Investigational Site, Portland, Oregon, United States
Investigational Site, Gettysburg, Pennsylvania, United States
Investigational Site, Hershey, Pennsylvania, United States
Investigational Site, Natrona Heights, Pennsylvania, United States
Investigational Site, Philadelphia, Pennsylvania, United States
Investigational Site, Pittsburgh, Pennsylvania, United States
Investigational Site, State College, Pennsylvania, United States
Investigational Site, Pawtucket, Rhode Island, United States
Investigational Site, Myrtle Beach, South Carolina, United States
Investigational Site, Cookeville, Tennessee, United States
Investigational Site, Austin, Texas, United States
Investigational Site, Fort Sam Houston, Texas, United States
Investigational Site, Galveston, Texas, United States
Investigational Site, Houston, Texas, United States
Investigational Site, Houston, Texas, United States
Investigational Site, Temple, Texas, United States
Investigational Site, Charlottesville, Virginia, United States
Investigational Site, Fort Belvoir, Virginia, United States
Investigational Site, Bellingham, Washington, United States
Investigational Site, Everett, Washington, United States
Investigational Site, Seattle, Washington, United States
Investigational Site, Morgantown, West Virginia, United States
Investigational Site, Madison, Wisconsin, United States
Name: Global Clinical Leader
Affiliation: Mallinckrodt
Role: STUDY_DIRECTOR