Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236093
• Other study ID #: C8278/2022/BP/US-CA
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2005
• Last updated: May 8, 2014
• Start date: October 2006

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.