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
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: Duragesic® (fentanyl) Therapeutic Transdermal System (TTS) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
Official title: A Study to Assess the Safety, Dose Conversion and Titration of DURAGESIC® (Fentanyl Transdermal System) in Pediatric Subjects With Chronic Pain Requiring Opioid Therapy
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence and severity of adverse events; Physical examination results and vital signs
Secondary outcome: Parent's global assessment of pain control on Days 1 and 16; Pain level assessed once in the morning and in the evening; Pain level at the time rescue medication is given and one hour afterwards; Pharmacokinetics
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients suffering from chronic pain of a well documented cause that requires
continuous administration of opioids
- 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 (15 days)
- Received the pain relief medication equivalent to at least 30 mg of oral morphine the
day prior to enrollment
- Available for careful monitoring during the first 72 hours following administration
of Duragesic®
- If female of child-bearing potential, must have a negative serum or urine pregnancy
test within 1 week of enrollment
Exclusion Criteria:
- Patients with skin disease that precludes application of Duragesic® or which may
affect the absorption of fentanyl
- Known sensitivity to fentanyl, other opioids, or adhesives
- Have a life expectancy less than the length of the primary treatment period (15 days)
- Have pain due to surgery, a clinically significant fever (i. e., above 38 C/100. 4 F),
a clinical condition that in the investigator's judgment prevents participation in
the study (e. g., clinically significant liver or kidney dysfunction), or are
currently being treated with ketoconazole, ritonavir or other disallowed concomitant
therapy
- Female patients who are pregnant or breast feeding
Locations and Contacts
Additional Information
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
Starting date: February 2000
Last updated: May 17, 2011
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