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

• Status: Completed
• Trial end date: 2001-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Fentanyl

Criteria

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