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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271414
• Other study ID #: CR005962
• Status: Completed
• Phase: Phase 3
• First received: December 30, 2005
• Last updated: May 16, 2011
• Start date: March 1999
• Est. completion date: March 2001

Study information

• Verified date: April 2010
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Duragesic® (fentanyl) Transdermal Therapeutic System (TTS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events; Physical examination results and vital signs; Pharmacokinetics
Secondary	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

External Links

•   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