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
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

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

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.
    

Intervention name(s): Durogesic® (fentanyl transdermal drug delivery system)
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain; opioid; fentanyl; transdermal; Durogesic; morphine