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

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.

Timeline

Start

2000-02

Primary completion

—

Completion

2002-04

Publications

• Results Finkel JC, Finley A, Greco C, Weisman SJ, Zeltzer L. Transdermal fentanyl in the management of children with chronic severe pain: results from an international study. Cancer. 2005 Dec 15;104(12):2847-57. doi: 10.1002/cncr.21497.

Drugs

Indications