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

May 16, 2011 updated by: Janssen Cilag S.A.S.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

34

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Cilag S.A.S.

Investigators

  • Study Director: Janssen-Cilag S.A.S. Clinical Trial, Janssen Cilag S.A.S.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002920

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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