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Brief Title: Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain
Official Title: A 4-week, Open-Label Extension Study of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain
Study ID: NCT00236093
Brief Summary: The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ (Oral Transmucosal Fentanyl Citrate \[OTFC\]) treatment in children with pain associated with cancer, sickle cell disease, or severe burns and breakthrough pain (BTP) who are receiving around the clock (ATC) opioid therapy.
Detailed Description:
Minimum Age: 3 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Children's Hospital of Arkansas, Little Rock, Arkansas, United States
Childrens Hospital of Orange, Orange, California, United States
Lucille Packard Childresns Hospital, Palo Alto, California, United States
Connecticut Childrens Medical, Hartford, Connecticut, United States
Childrens National Medical Center, Washington, District of Columbia, United States
Nemours Childrens Clinc, Jacksonville, Florida, United States
St. Joseph's Childrens Hopsital, Tampa, Florida, United States
Kapi'olani Medical Center, Honolulu, Hawaii, United States
University Hospitals of Iowa, Iowa City, Iowa, United States
David Center for Childrens Pain and Palliative Care, Hackensack, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
University of New Mexico, Albuquerque, New Mexico, United States
Children's Hospital at Montefiore, Bronx, New York, United States
Scottish Rite Children's Medical Center, Syracuse, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Duke University Hospital, Durham, North Carolina, United States
Akron Children's Hospital, Akron, Ohio, United States
Tod Childrens Hospital, Youngstown, Ohio, United States
Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Children's Cancer and Blood Disorders Center, San Antonio, Texas, United States
Methodist Hospital, San Antonio, Texas, United States
Sacred Heart Medical Center, Spokane, Washington, United States
West Virginia Univeristy, Morgantown, West Virginia, United States
Childrens Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Iwk Health Center, Halifax, Nova Scotia, Canada
San Jorge Childrens Medical, San Juan, , Puerto Rico
Name: John Messina
Affiliation: Cephalon
Role: STUDY_DIRECTOR