Clinical Use and Safety of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer

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: NCT00269763
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : May 19, 2011
Information provided by:
Alza Corporation, DE, USA

Brief Summary:
The purpose of this study is to establish the clinical utility and safety of fentanyl TTS (a transdermal patch delivering the narcotic pain reliever fentanyl) in the treatment of pain in patients with cancer.

Condition or disease Intervention/treatment Phase
Pain Cancer Drug: Fentanyl Transdermal Therapeutic System (TTS) Phase 3

Detailed Description:

This is a single-arm, non-randomized, open-label, multi-center trial to assess the safety and clinical utility of the fentanyl Transdermal Therapeutic System (TTS) for the treatment of pain in patients with cancer. Patients requiring narcotics for pain management are converted from conventional analgesics to oral morphine, and titrated to a stable dose prior to the initiation of fentanyl TTS. The stabilized morphine dose provides the basis for the calculation of the equi-analgesic dose of fentanyl TTS based on established analgesic potency ratios. Patients replace the fentanyl TTS patch every 3 days. Immediate-release morphine is available as rescue medication for breakthrough pain. The adequacy of analgesia, use of morphine rescue medication, and routine safety evaluations are obtained at scheduled intervals throughout the trial.

fentanyl patch

Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Use and Safety of TTS (Fentanyl) in the Management of Pain in Patients With Cancer
Study Start Date : October 1987
Study Completion Date : April 1988

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Assessment of pain relief; Rescue medication usage

Secondary Outcome Measures :
  1. Incidence and severity of adverse events

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:

  • Patients currently taking narcotic analgesics for relief of cancer pain
  • Able to communicate effectively
  • Living with a constant caretaker
  • Who have achieved a stabilized morphine dose that provides adequate pain control

Exclusion Criteria:

  • Patients with a life expectancy of less than 30 days
  • Having history of carbon dioxide (CO2) retention or other cardiac, respiratory or nervous system disease (precludes participation because of the potential for respiratory depression)
  • Has severe renal or hepatic insufficiency, active skin disease, a history of allergic reactions to narcotics, or a history of narcotic abuse prior to treatment with narcotics for cancer-related pain
  • Has a mental or psychiatric disease
  • If female of child-bearing potential, currently pregnant or not practicing an acceptable method contraception

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): NCT00269763

Sponsors and Collaborators
Alza Corporation, DE, USA
Study Director: Alza Corporation Clinical Trial Alza Corporation, DE, USA

Additional Information: Identifier: NCT00269763     History of Changes
Other Study ID Numbers: CR005983
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: April 2010

Keywords provided by Alza Corporation, DE, USA:

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