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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00271466
First received: December 30, 2005
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Drug: Duragesic® (fentanyl) Therapeutic Transdermal System (TTS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence and severity of adverse events; Physical examination results and vital signs

Secondary Outcome Measures:
  • 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

Enrollment: 199
Study Start Date: February 2000
Study Completion Date: April 2002
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

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00271466

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00271466     History of Changes
Other Study ID Numbers: CR005977
Study First Received: December 30, 2005
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014