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

Phase 4
18 Years
Not Enrolling

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Trial Information

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

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Janssen-Cilag S.A.S. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Cilag S.A.S.


France: Ministry of Health

Study ID:




Start Date:

June 2003

Completion Date:

May 2004

Related Keywords:

  • Pain
  • Fentanyl
  • Analgesia
  • Pain
  • Cancer pain
  • Opioid analgesia
  • Transdermal fentanyl
  • Patient-controlled analgesia