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Spots Global Cancer Trial Database for Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 3 Years

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: John Messina

Affiliation: Cephalon

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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