Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis (NCT00244153) | Clinical Trial Compass
UnknownPhase 1/2
Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis
Germany120 participantsStarted 2004-06
Plain-language 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
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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...), sub…
What they're measuring
1
primary endpoints: improvement on the visual analogue scale (VAS) of minimally 20mm on a scale from 0- 100mm