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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00271414
Recruitment Status : Completed
First Posted : January 2, 2006
Last Update Posted : May 17, 2011
Information provided by:
Janssen Pharmaceutica N.V., Belgium

Brief Summary:
The objective of this study is to assess the safety and clinical utility of Duragesic® 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 15-day Trial to Document the Safety, Clinical Utility and Pharmacokinetics of Duragesic (TTS Fentanyl) in the Treatment of Pediatric Subjects With Continuous Pain Requiring Opioid Therapy
Study Start Date : March 1999
Actual Study Completion Date : March 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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

Secondary Outcome Measures :
  1. Parent's assessment of pain relief, tolerability and convenience (pre-treatment and after patch changes); Investigator's/parent's global assessments on Day 16 of pain control, adverse events, and convenience; Daily pain levels; Rescue medication usage

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pediatric (age 2-12) patients suffering from continuous pain of a well-documented cause
  • currently requiring treatment of pain with a strong opioid and expected to continue to require treatment with a strong opioid for the next 7 days
  • prior therapy for pain included a minor analgesic, weak opioid, or strong opioid equivalent to the pain relief of 45 mg morphine or less a day

Exclusion Criteria:

  • Patients with a history of allergy or hypersensitivity to fentanyl or morphine
  • have active skin disease that precludes application of Duragesic® or which may affect the absorption of fentanyl
  • have a life expectancy was less than 1 month
  • have a clinical condition that in the investigator's judgment prevents participation in the study (e.g., clinically relevant liver dysfunction), plan to undergo a surgical procedure within 3 days of study entry, or are currently using protease inhibitors (HIV/AIDS treatment)
  • have participated in any other drug trial relating to pain control within one month of study entry or currently participating in any other study or research project which would interfere with this trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00271414

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
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Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
Additional Information:
Layout table for additonal information Identifier: NCT00271414    
Other Study ID Numbers: CR005962
First Posted: January 2, 2006    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: April 2010
Keywords provided by Janssen Pharmaceutica N.V., Belgium:
chronic pain
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General