NCT00269763

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (planned)
• Sponsor: Alza Corporation, DE, USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pain
• Cancer

Interventions

Type	Name	Description
DRUG	Fentanyl Transdermal Therapeutic System (TTS)

Timeline

• Start date: 1987-10-01
• Completion: 1988-04-01
• First posted: 2005-12-26
• Last updated: 2011-05-19