Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer

May 18, 2011 updated by: Alza Corporation, DE, USA

Efficacy of TTS Fentanyl in the Management of Pain in Patients With Malignancy - Study III

The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatment of chronic cancer pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Moderate to severe pain is experienced by about one-third of cancer patients during the intermediate stage of their disease. Currently used medications for the treatment of moderate to severe pain due to cancer often provide inadequate pain relief and require repeated oral administration of a narcotic. Providing prolonged, safe and effective pain relief on a continuous basis would be a major therapeutic advance in the management of cancer pain. This is an open-label pilot study to evaluate the safety and effectiveness of the fentanyl Transdermal Therapeutic System (TTS) in the management of chronic pain in patients with cancer. The initial dose of the fentanyl transdermal patch is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry. Four dosage strengths of the fentanyl transdermal patch are available as study medication, with a nominal delivery rate of 100, 75, 50 and 25 micrograms of fentanyl per hour. Multiple transdermal patches are worn when higher doses are required. Morphine sulfate is available as needed as rescue medication to treat breakthrough pain. After the initial application, the dose is titrated for each patient within a hospital setting over the course of 3 days, or as long as is necessary to achieve adequate pain control. Changes in dose during titration occur no more frequently than once every 24 hours. After an appropriate dose is reached, the transdermal patch is replaced every 72 hours with a new transdermal patch, applied to a fresh skin site. When discharged, patients enter a 3-week program of twice weekly nursing visits to monitor patient progress. Patients are evaluated at designated time intervals for pain intensity, vital signs, and serum fentanyl concentration. Records are kept of all concomitant medications administered during the study and any adverse events. After completion of the 3-week program, patients are given the opportunity to remain on the fentanyl Transdermal Therapeutic System (TTS) for long-term treatment of their chronic pain.

The TTS (fentanyl) transdermal patch starting dose is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry, titrated as needed to achieve adequate pain control. The patch is replaced every 72 hours. The treatment phase is 3 weeks.

Study Type

Interventional

Enrollment

7

Phase

  • Phase 3

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:

  • Patients with a diagnosis of intermediate stage of malignancy, operationally defined as non-localized or metastatic disease causing moderate to severe pain
  • Having a diagnosis of terminal disease, defined as life expectancy of six months or less, with moderate to severe pain associated with malignancy
  • Requiring treatment with a narcotic analgesic for relief of cancer pain
  • Having normal liver, kidney, and lung function, as determined by liver function tests, BUN, creatinine, and blood gases

Exclusion Criteria:

  • Patients with a history of allergic reaction to narcotics
  • Having a history of narcotic abuse prior to cancer diagnosis
  • Unable to communicate adequately to provide information assessing the effectiveness of treatment
  • Having active skin disease which precludes application of the transdermal system
  • Having a history of carbon dioxide (CO2) retention or respiratory problems and who, in the physician's judgment, should not use narcotics

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 intensity at designated time intervals

Secondary Outcome Measures

Outcome Measure
Pharmacokinetics; Incidence of adverse events

Collaborators and Investigators

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

Sponsor

Alza Corporation, DE, USA

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

May 1, 1986

Study Completion

February 1, 1988

Study Registration Dates

First Submitted

December 22, 2005

First Submitted That Met QC Criteria

December 22, 2005

First Posted (Estimate)

December 26, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005980

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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