Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer

• Status: Completed
• Trial end date: 1988-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatment of chronic cancer pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Patients with a diagnosis of intermediate stage of malignancy, operationally defined as non-localized or metastatic disease causing moderate to severe pain

• Having a diagnosis of terminal disease, defined as life expectancy of six months or less, with moderate to severe pain associated with malignancy

• Requiring treatment with a narcotic analgesic for relief of cancer pain

• Having normal liver, kidney, and lung function, as determined by liver function tests, BUN, creatinine, and blood gases

Exclusion Criteria:

• Patients with a history of allergic reaction to narcotics

• Having a history of narcotic abuse prior to cancer diagnosis

• Unable to communicate adequately to provide information assessing the effectiveness of treatment

• Having active skin disease which precludes application of the transdermal system

• Having a history of carbon dioxide (CO2) retention or respiratory problems and who, in the physician's judgment, should not use narcotics