Status:
COMPLETED
A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, Compared With Placebo in Patients With Osteoarthritis
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Osteoarthritis
Arthritis
Eligibility:
All Genders
41+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine if fentanyl, delivered through the skin via an adhesive patch, has a superior pain-relieving effect compared with placebo in patients with osteoarthritis pain ...
Detailed Description
Chronic, non-cancer pain may result from injury or illness, such as osteoarthritis or rheumatoid arthritis, which causes suffering and a reduction in the quality of life. Opioids, such as fentanyl, ar...
Eligibility Criteria
Inclusion
- Patients with osteoarthritis (OA) of the hip or the knee (as defined by the American College of Rheumatology) and radiological evidence of OA from the target joint
- patients must be in need of and waiting for hip or knee replacement
- patients with chronic pain for longer than 3 months for \>=20 days/month
- patients with moderate to severe OA pain of the target joint (VAS score \>=50 on a scale of 0-100), whose pain was not adequately controlled with weak opioids, with or without non-opioid pain medication
- women must be postmenopausal or using adequate contraception, have a negative pregnancy test at study initiation, and not be breastfeeding.
Exclusion
- Patients who had previously failed fentanyl therapy or had discontinued treatment due to adverse events
- known allergy or hypersensitivity to fentanyl or to the adhesives
- patients being treated for depression or epilepsy
- patients who received sedative hypnotics, anaesthetics and/or muscle relaxants in the week preceding the Run-In Period
- patients experiencing another type of continuous pain that stands out in comparison with OA pain
- patients with major trauma to the target joints, infection in these joints, or irreversible damage to these joints during the 6 months before the study.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT00236366
Start Date
June 1 2002
End Date
April 1 2004
Last Update
May 17 2011
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