A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Narcotic Pain Relief Therapy

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the safety of treatment with Duragesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50, 75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy. Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the subject's current narcotic pain relief therapy, and to the parameters for increasing the Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Patients suffering from chronic pain of a well documented cause that requires continuous administration of opioids

• Received opioids continuously for a minimum of 7 days prior to enrollment with a projected need for continuous opioids for at least the length of the primary treatment period (15 days)

• Received the pain relief medication equivalent to at least 30 mg of oral morphine the day prior to enrollment

• Available for careful monitoring during the first 72 hours following administration of Duragesic®

• If female of child-bearing potential, must have a negative serum or urine pregnancy test within 1 week of enrollment

Exclusion Criteria:

• Patients with skin disease that precludes application of Duragesic® or which may affect the absorption of fentanyl

• Known sensitivity to fentanyl, other opioids, or adhesives

• Have a life expectancy less than the length of the primary treatment period (15 days)

• Have pain due to surgery, a clinically significant fever (i.e., above 38 C/100.4 F), a clinical condition that in the investigator's judgment prevents participation in the study (e.g., clinically significant liver or kidney dysfunction), or are currently being treated with ketoconazole, ritonavir or other disallowed concomitant therapy

• Female patients who are pregnant or breast feeding