Status:
TERMINATED
Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain
Lead Sponsor:
Janssen Cilag S.A.S.
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with...
Detailed Description
Patients with cancer pain are frequently under-medicated with morphine. This is a 56-day open-label study of the efficacy and safety of self-administered fentanyl skin patches for cancer pain control ...
Eligibility Criteria
Inclusion
- Less than a month of opioid treatment over the past 3 months
- Proven cancer and chronic stable, cancer-related pain
- Pain control medication (aside from opioids) at the maximum authorized dose in the 24-hours preceding the first study visit
- A pain score of at least 4 on the VAS scale and pain that justifies intervention by opium-derived drugs in the opinion of the investigator
Exclusion
- Liver or kidney problems
- Previous heart, lung or nervous disorders
- Allergy to fentanyl
- Skin condition that might interfere with absorption of the fentanyl through the skin
- Surgery or chemotherapy in the month preceding the study or scheduled during the 56 days of the study
- History of substance abuse
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00236327
Start Date
June 1 2003
End Date
May 1 2004
Last Update
May 17 2011
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