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

NCT00271414 | Completed Phase 3

• 1 other identifier: CR005962
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Keywords

chronic pain; opioid; fentanyl; transdermal; Duragesic; morphine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

Duragesic® (fentanyl) Transdermal Therapeutic System (TTS) DRUG

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Related 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

MeSH Terms

Conditions

Chronic Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 30, 2005
• First Posted: January 2, 2006
• Study Start: March 1, 1999
• Study Completion: March 1, 2001
• Last Updated: May 17, 2011

Record last verified: 2010-04