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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00236093
First received: October 7, 2005
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Pain
Cancer
Sickle Cell Anemia
Severe Burns
Drug: ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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.

Study Start Date: October 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236093

  Show 28 Study Locations
Sponsors and Collaborators
Cephalon
Investigators
Study Director: John Messina Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00236093     History of Changes
Other Study ID Numbers: C8278/2022/BP/US-CA
Study First Received: October 7, 2005
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Sickle Cell

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Breakthrough Pain
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 01, 2014