The Clinical Use and Safety of TTS (Fentanyl) in the Management of Pain in Patients With Cancer
18 Years
N/A
Both
Pain, Cancer
Trial Information
The Clinical Use and Safety of TTS (Fentanyl) in the Management of Pain in Patients With Cancer
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assessment of pain relief; Rescue medication usage
Principal Investigator
Alza Corporation Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Alza Corporation, DE, USA
Authority:
United States: Institutional Review Board
Study ID:
CR005983
NCT ID:
NCT00269763
Start Date:
October 1987
Completion Date:
April 1988
Related Keywords:
- Pain
- Cancer
- patch
- pain
- fentanyl
- narcotic
- Cancer
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