Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain
Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Cancer; Sickle Cell Anemia; Severe Burns
Intervention: ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Cephalon Official(s) and/or principal investigator(s): John Messina, Study Director, Affiliation: Cephalon
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.
Clinical Details
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 design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Eligibility
Minimum age: 3 Years.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
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
Exclusion Criteria:
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
Locations and Contacts
San Jorge Childrens Medical, San Juan 00912, Puerto Rico
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, 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
Children's Hospital at Montefiore, Bronx, New York 10467, United States
Scottish Rite Children's Medical Center, Syracuse, New York 13210, United States
SUNY Upstate Medical University, Syracuse, New York 13210, United States
Duke University Hospital, Durham, North Carolina 27710, United States
Iwk Health Center, Halifax, Nova Scotia B3J3G9, Canada
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
Additional Information
Starting date: October 2006
Last updated: May 8, 2014
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