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

Sponsor:	Alza Corporation, DE, USA
Information provided by:	Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:	NCT00269763

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 III

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:

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

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

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:

Clinical use and safety of TTS (fentanyl) in the management of pain in patients with cancer This link exits the ClinicalTrials.gov site

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
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012