Clinical trial NCT00236093: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Cancer
Sickle Cell Anemia
Severe Burns
Keywords: Sickle Cell
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Children's Hospital of Arkansas
state: Arkansas
city: Orange
country: United States
facility: Childrens Hospital of Orange
state: California
city: Palo Alto
country: United States
facility: Lucille Packard Childresns Hospital
state: California
city: Hartford
country: United States
facility: Connecticut Childrens Medical
state: Connecticut
city: Washington
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Nemours Childrens Clinc
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Childrens Hopsital
state: Florida
city: Honolulu
country: United States
facility: Kapi'olani Medical Center
state: Hawaii
city: Iowa City
country: United States
facility: University Hospitals of Iowa
state: Iowa
city: Hackensack
country: United States
facility: David Center for Childrens Pain and Palliative Care
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Syracuse
country: United States
facility: Scottish Rite Children's Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Youngstown
country: United States
facility: Tod Childrens Hospital
state: Ohio
city: Hershey
country: United States
facility: Milton S Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Children's Cancer and Blood Disorders Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia Univeristy
state: West Virginia
city: Milwaukee
country: United States
facility: Childrens Hospital of Wisconsin
state: Wisconsin
city: Halifax
country: Canada
facility: Iwk Health Center
state: Nova Scotia
city: San Juan
country: Puerto Rico
facility: San Jorge Childrens Medical
Study officials:
affiliation: Cephalon
name: John Messina
role: STUDY_DIRECTOR
References: