Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain
A 4-week, Open-Label Extension Study of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain
1 other identifier
interventional
N/A
3 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedMay 9, 2014
May 1, 2014
2 months
October 7, 2005
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ treatment in children with pain and BTP who are receiving ATC opioid therapy.
Interventions
Eligibility Criteria
You may qualify if:
- Children are included in the study if all of the following criteria are met:
- The patient completed participation in ACTIQ double blind study in compliance with the protocol
- 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 (at the time of enrollment into the ACTIQ double blind study) and continues to weight at least 15kg
- The child must continue using ATC opioid therapy for pain associated with cancer, sickle cell disease, or severe burns and be opioid-tolerant. Opioid tolerant patients are defined as patients who have taken at least 1 mg/kg/day or 40mg/day or more of oral morphine (or an equianalgesic 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 transient flares of pain that require 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
- Girls who are postmenarch or sexually active must have a negative urine pregnancy test before entry into the study, 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 the mouth and sucking not biting the unit)
- The child may be an inpatient or outpatient
You may not qualify if:
- Children are excluded from participating in this study if 1 or more of the following criteria are met:
- 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 of the first dose of study drug administration
- 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 is receiving any experimental drug/therapy. NOTE: Children may not be participating concurrently in another study when the other study requires experimental drug therapy.
- The child is receiving any other treatment that, in the opinion of the investigator, could interfere with the pain response
- A female patient of childbearing potential, is pregnant, or is lactating (any girl becoming pregnant during the study will be withdrawn from the study)
- The child has, in the opinion of the investigator, a development delay that would interfere with the use of ACTIQ therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (28)
Children's Hospital of Arkansas
Little Rock, Arkansas, 72202, United States
Childrens Hospital of Orange
Orange, California, 92868, United States
Lucille Packard Childresns Hospital
Palo Alto, California, 94304, United States
Connecticut Childrens Medical
Hartford, Connecticut, 06106, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
Nemours Childrens Clinc
Jacksonville, Florida, 32207, United States
St. Joseph's Childrens Hopsital
Tampa, Florida, 33660, United States
Kapi'olani Medical Center
Honolulu, Hawaii, 96826, United States
University Hospitals of Iowa
Iowa City, Iowa, 52242, United States
David Center for Childrens Pain and Palliative Care
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
Scottish Rite Children's Medical Center
Syracuse, New York, 13210, 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 Childrens 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 Center
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 Univeristy
Morgantown, West Virginia, 99204, United States
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, 53201, United States
Iwk Health Center
Halifax, Nova Scotia, B3J3G9, Canada
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
Cephalon
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
October 1, 2006
Primary Completion
December 1, 2006
Last Updated
May 9, 2014
Record last verified: 2014-05