Status:
UNKNOWN
Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Rheumatic Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
Intraarticular application of opioids versus glucocorticosteroids versus placebo in knee arthritis study goals: assessment of effectiveness and tolerability of locally applied morphine, dexamethasone...
Detailed Description
Study background Patients with chronic inflammatory arthritis (e.g. rheumatoid arthritis, undifferentiated oligoarthritis, monarthritis) suffer from recurrent pain, functional impairment and impaired...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00244153
Start Date
June 1 2004
End Date
August 1 2007
Last Update
September 11 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Immanuel Krankenhaus
Berlin, Germany, 14109