Spots Global Cancer Trial Database for Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
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Trial Identification
Brief Title: Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
Official Title: A Double-Blind, Placebo-Comparison Study to Evaluate the Efficacy and Safety of ACTIQ® (Oral Transmucosal Fentanyl Citrate [OTFC®]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain
Study ID: NCT00236041
Interventions
Study Description
Brief Summary: The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with cancer and non-cancer pain who are receiving around-the-clock (ATC) opioid therapy and who require additional therapy for BTP episodes. This will be determined by the analysis of the pain intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage.
Detailed Description: The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with pain who are receiving around-the-clock (ATC) opioid therapy and who require additional therapy for BTP episodes. This will be determined by the analysis of the pain intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage. The secondary objectives are: * to evaluate the characteristics of BTP in children with pain, including their response to treatment * to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children with regard to time to adequate analgesia by utilizing a stop watch to measure the time for each unit of study drug in the double blind phase * to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the occurrence of inadequate analgesia as assessed by the use of rescue medication * to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the numbers of patients who withdraw from the study because of inadequate analgesia * to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the duration of analgesic effect by using the FPS-R administered at approximately 30, 45, and 60 minutes after the start of each unit of study drug after an optimal dosage is obtained * to determine the distribution of optimal doses of ACTIQ treatment for these children by age group (3 to under 6 years, 6 to under 11 years, and 11 to under 16 years) * to establish a safe and effective titration scheme for ACTIQ in these children during the open label phase * to evaluate the safety of ACTIQ treatment for these children through the assessment of adverse events, clinical laboratory assessments (serum chemistry and hematology), vital sign measurements (including blood pressure, heart rate, and respiration rate), hemoglobin-oxygen saturation level (SpO2, measured via pulse oximetry), electrocardiograms (ECGs), physical examinations, and level of sedation (measured by the University of Michigan Sedation Scale \[UMSS\]) * to characterize the pharmacokinetics profile of ACTIQ (fentanyl citrate) in these children * to investigate the exposure and efficacy relationship between plasma concentration of fentanyl and clinical measures of analgesia
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Arkansas, Little Rock, Arkansas, United States
UCLA Pediatric Pain Program, Los Angeles, California, United States
Childrens Hospital of Orange, Orange, California, United States
Lucille Packard Childrens Hospital, Palo Alto, California, United States
Connecticut Childrens Medical Center, Hartford, Connecticut, United States
Children's National Medical Center, Washington, District of Columbia, United States
Nemours Childrens Clinic, Jacksonville, Florida, United States
St. Joseph's Children's Hospital, Tampa, Florida, United States
Scottish Rite Children's Medical Center, Atlanta, Georgia, United States
Kapi'olani Medical Center, Honolulu, Hawaii, United States
Children's Memorial Center, Chicago, Illinois, United States
Children's Memorial Hospital, Chicago, Illinois, United States
University Hospitals of Iowa, Iowa City, Iowa, United States
Cardinal Glennon Children's Hospital, St. Louis, Missouri, United States
Hackensack University Medical Center, 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
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 Children's 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, 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 University, Morgantown, West Virginia, United States
Childrens Hospital of Wisconsin, Milwaukee, Wisconsin, United States
San Jorge Childrens Medical, San Juan, , Puerto Rico
Contact Details
Name: John Messina, Pharm D
Affiliation: Cephalon, Inc.
Role: STUDY_DIRECTOR
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