Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain

Condition(s) targeted: Pain

Intervention: fentanyl (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Janssen Cilag S.A.S.

Official(s) and/or principal investigator(s):
Janssen-Cilag S.A.S. Clinical Trial, Study Director, Affiliation: Janssen Cilag S.A.S.

The purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain. Higher doses are allowed by permission of the investigator and rescue oral morphine medication is allowed.

Official title: Evaluation of the Efficacy and Safety of Transdermal Fentanyl in Patients Suffering From Chronic Cancer Pain in an Ambulatory Setting

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Pain control level using a visual analog scale (VAS) at various time points and at the end of 56-day study. Percent pain reduction and percentage of patients having a score of 4 or lower compared to the baseline. Use of rescue medication.

Secondary outcome: Constipation and recorded use of laxatives, patient-assessed quality of life obtained by questionnaires and overall tolerance assessed at the end of 56-day study.

Detailed description: Patients with cancer pain are frequently under-medicated with morphine. This is a 56-day open-label study of the efficacy and safety of self-administered fentanyl skin patches for cancer pain control in patients in the home-care setting not previously using morphine. The first 15 days of the study are for dose stabilization and the rest of the study assesses pain control and quality of life at stable doses of medication. The dose is determined by the patient with oversight by the investigator, and rescue oral morphine medication can be used when necessary. The patient records all medication use in a diary and fills out questionnaires concerning pain control, intestinal function (constipation) and overall quality of life. The hypothesis is that patients will be able to control their cancer pain by self-administering transdermal fentanyl at home and that they will well tolerate the medication.

Individualized doses, with a target dose of 25 to 100 micrograms per hour of fentanyl for 56 days via skin patches applied every 3 days to deliver 25 to 100 micrograms of fentanyl per hour per patch; oral morphine as rescue medication for pain.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: - Less than a month of opioid treatment over the past 3 months -

Proven cancer and chronic stable, cancer-related pain - Pain control medication (aside

from opioids) at the maximum authorized dose in the 24-hours preceding the first study

visit - A pain score of at least 4 on the VAS scale and pain that justifies intervention

by opium-derived drugs in the opinion of the investigator

Exclusion Criteria: - Liver or kidney problems - Previous heart, lung or nervous disorders

- Allergy to fentanyl - Skin condition that might interfere with absorption of the

fentanyl through the skin - Surgery or chemotherapy in the month preceding the study or

scheduled during the 56 days of the study - History of substance abuse.

Assessment of the efficacy and tolerance of transdermal fentanyl in patients with chronic cancer pain in outpatient medicine

Starting date: June 2003
Ending date: May 2004
Last updated: December 16, 2005