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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236327
Recruitment Status : Terminated (Sponsor discontinued the study following the discovery of a number of incompletely sealed batches that were unusable.)
First Posted : October 12, 2005
Last Update Posted : May 17, 2011
Information provided by:
Janssen Cilag S.A.S.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: fentanyl Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Transdermal Fentanyl in Patients Suffering From Chronic Cancer Pain in an Ambulatory Setting
Study Start Date : June 2003
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00236327

Sponsors and Collaborators
Janssen Cilag S.A.S.
Study Director: Janssen-Cilag S.A.S. Clinical Trial Janssen Cilag S.A.S.

Additional Information: Identifier: NCT00236327     History of Changes
Other Study ID Numbers: CR002920
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: April 2010

Keywords provided by Janssen Cilag S.A.S.:
Cancer pain
Opioid analgesia
Transdermal fentanyl
Patient-controlled analgesia

Additional relevant MeSH terms:
Cancer Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General