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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269763
• Other study ID #: CR005983
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: May 18, 2011
• Start date: October 1987
• Est. completion date: April 1988

Study information

• Verified date: April 2010
• Source: Alza Corporation, DE, USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 1988
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Drug:
• Fentanyl Transdermal Therapeutic System (TTS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alza Corporation, DE, USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pain relief; Rescue medication usage
Secondary	Incidence and severity of adverse events

External Links

•   Clinical use and safety of TTS (fentanyl) in the management of pain in patients with cancer