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Spots Global Cancer Trial Database for NOLAN: Naproxen or Loratadine and Neulasta

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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