Rheumatoid Arthritis Clinical Trial
Official title:
Open-Label Study To Assess The Effect On Pain Control Of Durogesic (Fentanyl Transdermic Therapeutic System) Treatment In Subjects With Rheumatoid Arthritis Or Osteoarthritis Of The Knee Or Hip.
The purpose of this study is to assess the degree of pain control achieved by treatment with fentanyl, administered via adhesive patches applied to the skin ('transdermal system") in patients with rheumatoid arthritis or osteoarthritis of the knee or hip. Treatment will be administered fo r4 weeks, added on to existing therapy with other medications.
Status | Completed |
Enrollment | 264 |
Est. completion date | December 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must meet the American College of Rheumatology criteria for rheumatoid arthritis (RA) or osteoarthritis (OA) of the hip or knee and have moderate or severe pain that is not adequately controlled by other medications (paracetamol (acetaminophen), NSAIDs, COX-2 inhibitors, weak opioids) - OA patients must be in need of and waiting for hip or knee replacement - RA patients using disease modifying antirheumatic drugs (DMARDs) must have been on stable dose of medication for >=3 months. Exclusion Criteria: - Patients who have received regular treatment with strong opioids during the month prior to study - another continuous pain that stands out compared to RA or OA pain - skin disease or known allergy or hypersensitivity to fentanyl or to the adhesives - history of liver disease - new physical therapy or change in that therapy within one month of study - pregnant or nursing females, or those without adequate contraception. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Janssen Pharmaceutica N.V., Belgium |
Herrero-Beaumont G, Bjorneboe O, Richarz U. Transdermal fentanyl for the treatment of pain caused by rheumatoid arthritis. Rheumatol Int. 2004 Nov;24(6):325-32. Epub 2004 Oct 5. — View Citation
Le Loët X, Pavelka K, Richarz U. Transdermal fentanyl for the treatment of pain caused by osteoarthritis of the knee or hip: an open, multicentre study. BMC Musculoskelet Disord. 2005 Jun 15;6:31. — View Citation
Pavelka K, Le Loet X, Bjorneboe O, Herrero-Beaumont G, Richarz U. Benefits of transdermal fentanyl in patients with rheumatoid arthritis or with osteoarthritis of the knee or hip: an open-label study to assess pain control. Curr Med Res Opin. 2004 Dec;20( — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of pain control (excellent, good, moderate, poor, very poor) and Pain Assessment Questionnaire at baseline and then weekly through Day 28. | |||
Secondary | Incidence of adverse events throughout study; efficacy of anti-nausea treatment (weekly); SF-36 Quality of Life Questionnaire and Health Assessment Questionnaire (HAQ) at start of treatment and Day 28. |
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