Clinical Use and Safety of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer
Information source: Alza Corporation, DE, USA
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Cancer
Intervention: Fentanyl Transdermal Therapeutic System (TTS) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alza Corporation, DE, USA Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA
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.
Clinical Details
Official title: The Clinical Use and Safety of TTS (Fentanyl) in the Management of Pain in Patients With Cancer
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Assessment of pain relief; Rescue medication usage
Secondary outcome: Incidence and severity of adverse events
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Clinical use and safety of TTS (fentanyl) in the management of pain in patients with cancer
Starting date: October 1987
Ending date: April 1988
Last updated: April 6, 2007
|
