A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Fentanyl

Criteria

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.