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

May 16, 2011 updated by: Janssen Pharmaceutica N.V., Belgium

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence and severity of adverse events; Physical examination results and vital signs; Pharmacokinetics

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutica N.V., Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Study Completion (Actual)

March 1, 2001

Study Registration Dates

First Submitted

December 30, 2005

First Submitted That Met QC Criteria

December 30, 2005

First Posted (Estimate)

January 2, 2006

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005962

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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