A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the safety and clinical utility of DuragesicÂ® 12.5
      micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the
      treatment of children ages 2 to 12 with continuous pain requiring narcotic pain relief
      therapy. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be
      assessed.
    

Detailed description: 
      A new dosage strength of Duragesic® TTS patch was developed to deliver 12.5 micrograms of
      fentanyl per hour, which is considered to be equi-analgesic to a daily dose of 45 mg of
      morphine administered orally, and considered a safe starting dose in children aged 2 to 12
      years. This is a single-arm, non-randomized, open-label, 15-day multicenter trial to
      determine the safety, clinical utility, and pharmacokinetics of Duragesic® in pediatric
      subjects who require treatment with a potent opioid for the management of continuous pain,
      allowing individual titration. After the 15-day primary treatment period, subjects may, at
      the investigator's discretion, continue long-term treatment with Duragesic® for a period of
      up to 1 year.

      All subjects start treatment with a 12.5 micrograms/hour patch. Immediate-release morphine is
      available to treat breakthrough pain. The patches are replaced every 72 hours. The objective
      is to have subjects pain-free as much as possible, using the least possible rescue
      medication. Duragesic® dose increases are considered based on rescue medication consumption
      and pain assessment. Where a subject is maintained pain-free with a daily consumption of 45
      mg of rescue morphine or more, a dose increase of Duragesic® with 12.5 micrograms/hour is
      permitted. No increase in Duragesic® dose is to be performed within the 72-hour dosing
      interval. The primary outcome of this study is an assessment of safety, including the
      incidence and severity of adverse events, and physical examination results and vital signs.
      Clinical utility is assessed by the parent's treatment assessment of pain relief,
      tolerability and convenience (pre-treatment and after each patch change); the investigator's
      and the parent's global assessments on Day 16 of pain control, adverse events, and
      convenience; daily measures of pain levels; use of rescue medication; and the child's play
      performance. Pharmacokinetics will also be assessed. Duragesic® will be applied to the upper
      torso, and replaced every 72 hours. The initial dose is one patch with a fentanyl delivery
      rate of approximately 12.5 micrograms/hour. Dose increases in steps of 12.5 micrograms/hour
      are considered if pain is inadequately controlled. The treatment phase is 15 days.
    

Intervention name(s): Duragesic® (fentanyl) Transdermal Therapeutic System (TTS)
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; Duragesic; morphine