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A 4-Week, Open-Label Extension Study of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain

Phase 2
3 Years
15 Years
Not Enrolling
Pain, Cancer, Sickle Cell Anemia, Severe Burns

Thank you

Trial Information

A 4-Week, Open-Label Extension Study of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Principal Investigator

John Messina

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Pain
  • Cancer
  • Sickle Cell Anemia
  • Severe Burns
  • Sickle Cell
  • Anemia
  • Anemia, Sickle Cell



Childrens National Medical Center Washington, District of Columbia  
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Akron Children's Hospital Akron, Ohio  44308-1062
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Methodist Hospital Houston, Texas  77030
SUNY Upstate Medical University Syracuse, New York  13210
University of New Mexico Albuquerque, New Mexico  87131
Sacred Heart Medical Center Spokane, Washington  99204
Children's Hospital of Arkansas Little Rock, Arkansas  72202
Childrens Hospital of Orange Orange, California  92868
Kapi'olani Medical Center Honolulu, Hawaii  96826
University Hospitals of Iowa Iowa City, Iowa  52242
Children's Hospital at Montefiore Bronx, New York  10467
Duke University Hospital Durham, North Carolina  27710
Milton S Hershey Medical Center Hershey, Pennsylvania  17033
Children's Cancer and Blood Disorders Center San Antonio, Texas  78207
Childrens Hospital of Wisconsin Milwaukee, Wisconsin  53201
Lucille Packard Childresns Hospital Palo Alto, California  94304
Connecticut Childrens Medical Hartford, Connecticut  06106
Nemours Childrens Clinc Jacksonville, Florida  32207
St. Joseph's Childrens Hopsital Tampa, Florida  33660
David Center for Childrens Pain and Palliative Care Hackensack, New Jersey  07601
Scottish Rite Children's Medical Center Syracuse, New York  13210
Tod Childrens Hospital Youngstown, Ohio  44501
West Virginia Univeristy Morgantown, West Virginia  99204