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

Study Overview
=================
Brief 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.

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

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

Conditions
-----------------
Pain, Cancer

Intervention / Treatment
-----------------
* Drug: Fentanyl Transdermal Therapeutic System (TTS)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fentanyl Transdermal Therapeutic System (TTS)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain relief; Rescue medication usage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patch, pain, fentanyl, narcotic, Cancer