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

Alza Corporation

Status and phase

Completed

Phase 3

Conditions

Cancer

Pain

Treatments

Drug: Fentanyl Transdermal Therapeutic System (TTS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00269763

CR005983

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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