Pain Clinical Trial
Official title:
The Clinical Use and Safety of TTS (Fentanyl) in the Management of Pain in Patients With Cancer
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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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