Trial Information

Efficacy of TTS Fentanyl in the Management of Pain in Patients With Malignancy - Study III

Moderate to severe pain is experienced by about one-third of cancer patients during the
intermediate stage of their disease. Currently used medications for the treatment of
moderate to severe pain due to cancer often provide inadequate pain relief and require
repeated oral administration of a narcotic. Providing prolonged, safe and effective pain
relief on a continuous basis would be a major therapeutic advance in the management of
cancer pain. This is an open-label pilot study to evaluate the safety and effectiveness of
the fentanyl Transdermal Therapeutic System (TTS) in the management of chronic pain in
patients with cancer. The initial dose of the fentanyl transdermal patch is calculated
based upon the equi-analgesic potency ratio of the narcotic used prior to study entry. Four
dosage strengths of the fentanyl transdermal patch are available as study medication, with a
nominal delivery rate of 100, 75, 50 and 25 micrograms of fentanyl per hour. Multiple
transdermal patches are worn when higher doses are required. Morphine sulfate is available
as needed as rescue medication to treat breakthrough pain. After the initial application,
the dose is titrated for each patient within a hospital setting over the course of 3 days,
or as long as is necessary to achieve adequate pain control. Changes in dose during
titration occur no more frequently than once every 24 hours. After an appropriate dose is
reached, the transdermal patch is replaced every 72 hours with a new transdermal patch,
applied to a fresh skin site. When discharged, patients enter a 3-week program of twice
weekly nursing visits to monitor patient progress. Patients are evaluated at designated
time intervals for pain intensity, vital signs, and serum fentanyl concentration. Records
are kept of all concomitant medications administered during the study and any adverse
events. After completion of the 3-week program, patients are given the opportunity to
remain on the fentanyl Transdermal Therapeutic System (TTS) for long-term treatment of their
chronic pain.

The TTS (fentanyl) transdermal patch starting dose is calculated based upon the
equi-analgesic potency ratio of the narcotic used prior to study entry, titrated as needed
to achieve adequate pain control. The patch is replaced every 72 hours. The treatment
phase is 3 weeks.