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 for 4 weeks, added on to existing therapy with other medications.
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.
Conditions
OsteoarthritisArthritisRheumatoid Arthritis
Study Type
Interventional
Study Design
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further Details
Primary Outcome Measures:
- Assessment of pain control (excellent, good, moderate, poor, very poor) and Pain Assessment Questionnaire at baseline and then weekly through Day 28.
Secondary Outcome Measures:
- 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.
Study Start
May 2001
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
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
Total Enrolment
336
Contact Details
Click here to see published results of this trial.
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