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

This study has been terminated.
(Sponsor discontinued the study following the discovery of a number of incompletely sealed batches that were unusable.)
Sponsor:
Information provided by:
Janssen Cilag S.A.S.
ClinicalTrials.gov Identifier:
NCT00236327
First received: October 7, 2005
Last updated: May 16, 2011
Last verified: April 2010
  Purpose

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 Intervention Phase
Pain
Drug: fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Janssen Cilag S.A.S.:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 34
Study Start Date: June 2003
Study Completion Date: May 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236327

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00236327     History of Changes
Other Study ID Numbers: CR002920
Study First Received: October 7, 2005
Last Updated: May 16, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014