Status:
COMPLETED
Clinical Use and Safety of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Pain
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 1987
Trial Type :
INTERVENTIONAL
End Date :
April 1 1988
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00269763
Start Date
October 1 1987
End Date
April 1 1988
Last Update
May 19 2011
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