A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic 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 of treatment with Duragesic® (a
      transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50,
      75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy.
      Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the
      subject's current narcotic pain relief therapy, and to the parameters for increasing the
      Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the
      bloodstream during treatment) will also be assessed.
    

Detailed description: 
      This is a single-arm, nonrandomized, open-label, multicenter trial designed to enroll a total
      of approximately 200 pediatric subjects with moderate to severe chronic pain due to malignant
      or nonmalignant disease. Subjects must have received opioids continuously for a minimum of 7
      days prior to enrollment with a projected need for continuous opioids for at least the length
      of the primary treatment period. Subjects must also have received the equivalent of at least
      30 mg of oral morphine on the day prior to enrollment. Subjects were enrolled into 3 age
      cohorts including 2 to <6 years, 6 to <12 years, and 12 to <16 years. The study consisted of
      a 15-day primary treatment period. After the 15-day primary treatment period, subjects may,
      at the investigator's discretion, continue long-term treatment with Duragesic® as long as
      medically appropriate. The objective of this study is to provide an evaluation of the safety
      of Duragesic® in pediatric subjects who require treatment with a potent opioid for the
      management of chronic pain. On Day 1, subjects are converted from oral or parenteral opioids
      to Duragesic® by calculating the previous 24-hour opioid analgesic requirement. This amount
      is then converted to the equi-analgesic oral morphine dose, and then used to determine the
      corresponding Duragesic® dose. Short-acting oral or parenteral opioids are used as rescue
      medication at any time during the study to treat breakthrough pain (pain not adequately
      controlled by Duragesic®). Following initiation of Duragesic® treatment using the recommended
      dose, subjects are titrated upwards (no more frequently than every 3 days after the initial
      dose) until analgesic effectiveness is attained. Titration is based on supplemental opioid
      consumption, such that the dose of Duragesic® is increased by 12.5 micrograms/hour for every
      45 mg of oral morphine consumed on the 2nd or 3rd days following the last patch change, up to
      a maximum increase of 25 micrograms/hour at any one time. The primary endpoint of this trial
      is the determination of the safety profile of Duragesic® in the defined target population.
      Safety is assessed by monitoring adverse events, vital sign measurements, and through
      physical examination. In addition, respiratory rate and level of sedation are closely
      monitored during the first 72 hours. The assessment of clinical utility includes the parent's
      global assessment of pain control on Days 1 and 16, the pain level assessed by the parent and
      the patient twice daily, once in the morning and in the evening (or assessed by the parent
      only if the patient is younger than age 6), the pain level at the time rescue medication is
      given and one hour afterwards, the child's play performance, and a quality-of-life child
      health questionnaire (CHQ) used to measure the physical, psychosocial functioning and well
      being of children 5 years of age. During the primary treatment period, serum fentanyl
      concentrations are also measured. Sparse pharmacokinetic sampling is incorporated into the
      trial design to facilitate population pharmacokinetic analysis.
    

Intervention name(s): DuragesicÂ® (fentanyl) Therapeutic Transdermal 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: opioid; fentanyl; Duragesic; transdermal; chronic pain; morphine