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Brief Title: NOLAN: Naproxen or Loratadine and Neulasta
Official Title: Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim
Study ID: NCT01712009
Brief Summary: The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.
Detailed Description: In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis. Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Research Site, Muscle Shoals, Alabama, United States
Research Site, Anaheim, California, United States
Research Site, Fullerton, California, United States
Research Site, Santa Maria, California, United States
Research Site, Santa Rosa, California, United States
Research Site, Torrance, California, United States
Research Site, Whittier, California, United States
Research Site, Denver, Colorado, United States
Research Site, Golden, Colorado, United States
Research Site, Littleton, Colorado, United States
Research Site, Norwich, Connecticut, United States
Research Site, Stamford, Connecticut, United States
Research Site, Boynton Beach, Florida, United States
Research Site, Daytona Beach, Florida, United States
Research Site, Daytona Beach, Florida, United States
Research Site, Fort Lauderdale, Florida, United States
Research Site, Lakeland, Florida, United States
Research Site, New Port Richey, Florida, United States
Research Site, Plantation, Florida, United States
Research Site, Stuart, Florida, United States
Research Site, Augusta, Georgia, United States
Research Site, Thomasville, Georgia, United States
Research Site, Elmhurst, Illinois, United States
Research Site, Gurnee, Illinois, United States
Research Site, Mount Vernon, Illinois, United States
Research Site, Skokie, Illinois, United States
Research Site, Urbana, Illinois, United States
Research Site, Indianapolis, Indiana, United States
Research Site, South Bend, Indiana, United States
Research Site, Sioux City, Iowa, United States
Research Site, Waterloo, Iowa, United States
Research Site, Hutchinson, Kansas, United States
Research Site, Lexington, Kentucky, United States
Research Site, Louisville, Kentucky, United States
Research Site, Mount Sterling, Kentucky, United States
Research Site, Paducah, Kentucky, United States
Research Site, Alexandria, Louisiana, United States
Research Site, Lafayette, Louisiana, United States
Research Site, Marrero, Louisiana, United States
Research Site, Shreveport, Louisiana, United States
Research Site, Cumberland, Maryland, United States
Research Site, Randallstown, Maryland, United States
Research Site, Rockville, Maryland, United States
Research Site, Westminster, Maryland, United States
Research Site, Lowell, Massachusetts, United States
Research Site, Battle Creek, Michigan, United States
Research Site, Duluth, Minnesota, United States
Research Site, Saint Cloud, Minnesota, United States
Research Site, Jackson, Mississippi, United States
Research Site, Jefferson City, Missouri, United States
Research Site, Kansas City, Missouri, United States
Research Site, Saint Joseph, Missouri, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Billings, Montana, United States
Research Site, Omaha, Nebraska, United States
Research Site, Nashua, New Hampshire, United States
Research Site, Denville, New Jersey, United States
Research Site, East Syracuse, New York, United States
Research Site, Johnson City, New York, United States
Research Site, Gastonia, North Carolina, United States
Research Site, Hickory, North Carolina, United States
Research Site, Pinehurst, North Carolina, United States
Research Site, Massillon, Ohio, United States
Research Site, Zanesville, Ohio, United States
Research Site, Bend, Oregon, United States
Research Site, Bethlehem, Pennsylvania, United States
Research Site, Langhorne, Pennsylvania, United States
Research Site, Florence, South Carolina, United States
Research Site, Watertown, South Dakota, United States
Research Site, Bristol, Tennessee, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Corpus Christi, Texas, United States
Research Site, Corpus Christi, Texas, United States
Research Site, Plano, Texas, United States
Research Site, Ogden, Utah, United States
Research Site, Chesapeake, Virginia, United States
Research Site, Spokane, Washington, United States
Research Site, Huntington, West Virginia, United States
Research Site, Janesville, Wisconsin, United States
Research Site, Madison, Wisconsin, United States
Research Site, Racine, Wisconsin, United States
Research Site, Wauwatosa, Wisconsin, United States
Research Site, Weston, Wisconsin, United States
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR