Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
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
1 other identifier
interventional
38
2 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 cancer
Started Apr 2004
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedMay 9, 2014
May 1, 2014
October 7, 2005
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity differences as measured by the FPS-R
Secondary Outcomes (5)
Time to adequate analgesia
Duration of analgesia
Percentage of BTP episodes requiring rescue medication, or for which oversedation occurs
Amount of rescue medication
Distribution of optimal doses
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent of the parent or legal guardian and patient assent, when appropriate, is obtained. (Lack of assent cannot be overturned.)
- The child is aged 3 to under 16 years and weighs at least 15 kg.
- The child must be using ATC opioid therapy for pain associated with cancer and be opioid-tolerant. NOTE: This requirement is defined as the patient receiving at least 1 mg/kg/day or 40 mg/day or more of oral morphine (or an equi-analgesic dosage of another opioid) or at least 25 mcg/hour of transdermal fentanyl for at least 7 days, (ATC opioid therapy may be administered as patient-controlled analgesia \[PCA\]).
- The child must be experiencing episodes of BTP (defined as a transient flare of pain that requires a bolus of medication as treatment) as follows:
- patients with cancer must be experiencing an average of at least 1 BTP episode a day.
- patients with non-cancer related pain must be experiencing an average of 2 BTP episodes a day.
- The child has an average daily pain score of 6 or less (of 10) on the FPS-R.
- Girls who are postmenarche or sexually active must have a negative urine pregnancy test prior to the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence.
- The child, in the opinion of the investigator, is able to administer ACTIQ treatment effectively (ie, adequately moving the unit around in the mouth and sucking, not biting, the unit).
- The child must be an inpatient.
You may not qualify if:
- The child has pain uncontrolled by therapy, as determined by the investigator, that could adversely impact the safety of the patient or could be compromised by treatment with ACTIQ.
- The child has known or suspected hypersensitivities/allergies or other contraindications to any ACTIQ component.
- The child has received monoamine oxidase inhibitors (MAOIs) within 14 days before the first ACTIQ treatment.
- The child has moderate to severe oral mucositis.
- The child has a neuromuscular disease, significant renal impairment, or significant hepatic impairment as determined by the investigator.
- The child has any other medical condition or is receiving concomitant medication/therapy that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise data collection.
- The child has received any experimental drug/therapy within 14 days of the first ACTIQ treatment. NOTE: Children may not be participating concurrently in another study when the other study requires experimental drug therapy.
- A child's exacerbations of pain are only associated with medical procedures (such as radiation therapy, wound dressing, and bone marrow aspiration).
- The child is receiving any other treatment that, in the opinion of the investigator, could interfere with the pain response.
- For a female patient of childbearing potential: is pregnant or lactating. (Any female patient becoming pregnant during the study will be withdrawn from the study.)
- The child has, in the opinion of the investigator, developmental delay that would interfere with the use of ACTIQ therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (31)
Children's Hospital of Arkansas
Little Rock, Arkansas, 72202, United States
UCLA Pediatric Pain Program
Los Angeles, California, 90095, United States
Childrens Hospital of Orange
Orange, California, 92868, United States
Lucille Packard Childrens Hospital
Palo Alto, California, 94304, United States
Connecticut Childrens Medical Center
Hartford, Connecticut, 06106, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Nemours Childrens Clinic
Jacksonville, Florida, 32207, United States
St. Joseph's Children's Hospital
Tampa, Florida, 33607, United States
Scottish Rite Children's Medical Center
Atlanta, Georgia, 30342, United States
Kapi'olani Medical Center
Honolulu, Hawaii, 96826, United States
Children's Memorial Center
Chicago, Illinois, 60614, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
University Hospitals of Iowa
Iowa City, Iowa, 52242, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Tod Children's Hospital
Youngstown, Ohio, 44501, United States
Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Vanderbilt University Medical
Nashville, Tennessee, 37232, United States
Children's Cancer and Blood Disorders Center
San Antonio, Texas, 78207, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
West Virginia University
Morgantown, West Virginia, 99204, United States
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, 53201, United States
San Jorge Childrens Medical
San Juan, 00912, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Messina, Pharm D
Cephalon, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
April 1, 2004
Study Completion
August 1, 2006
Last Updated
May 9, 2014
Record last verified: 2014-05