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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

Page last updated: August 20, 2015

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