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

Phase 3
18 Years
Not Enrolling
Pain, Cancer

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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:


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


United States: Institutional Review Board

Study ID:




Start Date:

October 1987

Completion Date:

April 1988

Related Keywords:

  • Pain
  • Cancer
  • patch
  • pain
  • fentanyl
  • narcotic
  • Cancer