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

This study has been completed.
Sponsor:
Information provided by:
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00269763
First received: December 22, 2005
Last updated: May 18, 2011
Last verified: April 2010
  Purpose

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 Intervention Phase
Pain
Cancer
Drug: Fentanyl Transdermal Therapeutic System (TTS)
Phase 3

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: The Clinical Use and Safety of TTS (Fentanyl) in the Management of Pain in Patients With Cancer

Resource links provided by NLM:


Further study details as provided by Alza Corporation, DE, USA:

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

Secondary Outcome Measures:
  • Incidence and severity of adverse events

Estimated Enrollment: 32
Study Start Date: October 1987
Estimated Study Completion Date: April 1988
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00269763

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00269763     History of Changes
Other Study ID Numbers: CR005983
Study First Received: December 22, 2005
Last Updated: May 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Alza Corporation, DE, USA:
patch
pain
fentanyl
narcotic
Cancer

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 October 16, 2014