A Study to Assess the Safety and Effectiveness of Durogesic (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Long-term Narcotic Pain Relief Therapy

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00271453
First received: December 30, 2005
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to assess the effectiveness and safety of Durogesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children with chronic pain requiring long-term narcotic pain relief therapy.


Condition Intervention Phase
Chronic Pain
Drug: Durogesic® (fentanyl transdermal drug delivery system)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Assess the Safety, Efficacy and Pharmacokinetics of Durogesic (Fentanyl Transdermal Drug Delivery System) in the Treatment of Pediatric Patients With Chronic Pain Requiring Long-term Opioid Therapy

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Patient assessment of treatment at Day 15; Pain level assessed once in the morning and in the evening; Amount of rescue medication that the patient requires; Pain level at the time rescue medication is given and one hour afterwards

Secondary Outcome Measures:
  • Investigator and parent global assessment of the patient's treatment with respect to pain control, side effects and convenience; Pharmacokinetics; Incidence of adverse events

Enrollment: 41
Study Start Date: February 1996
Study Completion Date: October 1998
Detailed Description:

The objective of this study is to establish the analgesic efficacy, safety and pharmacokinetic profile of Durogesic® in the treatment of pediatric patients with chronic pain requiring long-term opioid therapy. Patients may be in-patients or treated at home. This study consists of three phases: a pre-trial phase, a treatment phase, and a follow-up phase. During the pre-trial phase, patients receive immediate-release oral morphine or sustained-release morphine (minimum daily dose of morphine is 30 mg/day) for at least 48 hours immediately prior to entry into the study. Patients achieving adequate pain relief in the pre-trial phase will enter the treatment phase and will be switched over to Durogesic®. The dose of Durogesic® will be calculated from the patient's daily morphine requirement, using the conversion regimen. The minimum starting dose is one patch with a fentanyl delivery rate of approximately 25 micrograms/hour. Titration in steps of 25 micrograms/hour is permitted to achieve adequate pain control. The maximum allowable dose is 300 micrograms/hour. The Durogesic® patch is applied to an area of flat skin on the upper body or upper arm, and replaced every 72 hours. The treatment phase of this study will last for 15 days (5 consecutive patch changes). Immediate-release morphine is available as rescue medication to treat breakthrough pain. Upon completion of the treatment phase, the patient may continue to receive Durogesic® therapy in the long-term follow-up phase, as long as the patient, parent or the investigator feels that it is beneficial. The primary measures of effectiveness include the patient's assessment of treatment at Day 15, pain level assessed by the patient twice daily, once in the morning and in the evening (or assessed by the parent if the patient is younger than age 5), the amount of rescue medication that the patient requires, and the pain level at the time rescue medication is given and one hour afterwards. In patients where venous access (either central or peripheral) is available, or if blood is being taken for some other purpose, blood samples will be taken to determine serum fentanyl concentrations. Safety evaluations will include the incidence of adverse events, clinical laboratory tests, assessment of the skin at the site of patch application, and vital signs. Durogesic® will be applied to the upper body or upper arm, and replaced every 72 hours. The minimum starting dose is one patch with a fentanyl delivery rate of approximately 25 micrograms/hour, titrated to achieve adequate pain control, up to a maximum dose of 300 micrograms/hour. The treatment phase is 15 days.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a confirmed malignancy (whose pain is judged by the investigator to be caused by the malignancy), or patients with other life-threatening/terminal disease whose pain requires treatment with strong opioid analgesia
  • requiring treatment of pain with a strong opioid and who are expected to continue to require treatment with a strong opioid for the duration of the study
  • receiving a stable dose of immediate-release oral morphine or sustained-release morphine (minimum daily dose of morphine is 30 mg/day) for at least 48 hours immediately prior to entry into the study

Exclusion Criteria:

  • Patients with a history of allergy or hypersensitivity to fentanyl or morphine
  • have active skin disease that precludes application of Durogesic® or which may affect the absorption of fentanyl
  • have a clinical condition that in the investigator's judgment prevents participation in the study
  • have participated in any other drug trial relating to pain control within one month of study entry
  • currently participating in any other study or research project which would interfere with this trial.
  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: NCT00271453

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00271453     History of Changes
Other Study ID Numbers: CR005950
Study First Received: December 30, 2005
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
chronic pain
opioid
fentanyl
transdermal
Durogesic
morphine

Additional relevant MeSH terms:
Chronic Pain
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 July 31, 2014