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

May 8, 2014 updated by: Cephalon

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

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.

Study Overview

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J3G9
        • IWK Health Center
      • San Juan, Puerto Rico, 00912
        • San Jorge Childrens Medical
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Children's Hospital of Arkansas
    • California
      • Orange, California, United States, 92868
        • Childrens Hospital of Orange
      • Palo Alto, California, United States, 94304
        • Lucille Packard Childresns Hospital
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Childrens Medical
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Childrens National Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Childrens Clinc
      • Tampa, Florida, United States, 33660
        • St. Joseph's Childrens Hopsital
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapi'olani Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University Hospitals of Iowa
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • David Center for Childrens Pain and Palliative Care
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Bronx, New York, United States, 10467
        • Children's Hospital at Montefiore
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Scottish Rite Children's Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital
      • Youngstown, Ohio, United States, 44501
        • Tod Childrens Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hospital for Children
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Methodist Hospital
      • San Antonio, Texas, United States, 78207
        • Children's Cancer and Blood Disorders Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Sacred Heart Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 99204
        • West Virginia Univeristy
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Childrens Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: John Messina, Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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