Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis

• Status: Unknown status
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Intraarticular application of opioids versus glucocorticosteroids versus placebo in knee arthritis

study goals: assessment of effectiveness and tolerability of locally applied morphine, dexamethasone or placebo in knee arthritis

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Dexamethasone; Morphine

Criteria

Inclusion Criteria:

• Arthritis according to the American Rheumatism Association or osteoarthritis of the knee

• age older than 18 years

• active gonarthritis in the setting of a rheumatic inflammatory disease such as rheumatoid arthritis, spondyloarthropathies, undifferentiated oligoarthritis or monarthritis since at least 4 weeks with proof of joint or ostearthritis of the knee effusion in ultrasound

• visual analogue scale (pain) >30 mm

• weight between 50 and 90 kg

• signed informed consent

• negative urine pregnancy test in women of child-bearing potential

Exclusion Criteria:

• pregnancy / lactation

• severe infection, suspicion for opportunistic infection within the last 2 months (herpes zoster, cytomegaly-, pneumocystis carinii-infection), HIV- infection

• malignant disease

• severe cardiac, renal, hematologic, pulmonary, neurologic, gastrointestinal (amongst others gastric or duodenal ulcer) or hepatic (viral hepatitis, toxic liver disease etc) disease, uncontrolled high blood pressure, recurrent thrombosis/ embolism

• psychiatric disease

• significant bone marrow dysfunction with impaired hematopoiesis

• one of the following laboratory findings: thrombocytopenia < 100 /nl, Quick < 50%

• significant pathological findings in physical examination, especially findings indicating an infectious cause for arthritis (septic arthritis) or Lyme arthritis

• participation in clinical trials within the last 30 days

• intake of illegal drugs (such as cocaine, heroin...), substance abuse (alcohol, excessive intake of analgetic drugs, benzodiazepines)

• intake of anticoagulating drugs