Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00244153
• Date of registration: 25/10/2005
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis
• Scientific title: Intraarticular Application of Opioids Versus Glucocorticosteroids Versus Placebo in Rheumatoid Arthritis
• Date of first enrolment: June 2004
• Target sample size: 120
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00244153
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Germany

Contacts

• Name: Joachim Sieper, Prof.
• Affiliation: Charité Campus Benjamin-Franklin, Rheumatology

• Name: Andreas Krause, Prof.

• Name: Joachim Sieper, Prof.

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatic Disease

Intervention(s)

Drug: intraarticular morphine

Drug: intraarticular dexamethasone

Primary Outcome(s)

primary endpoints: improvement on the visual analogue scale (VAS) of minimally 20mm on a scale from 0- 100mm

Secondary Outcome(s)

secondary end points: improvement of the numeric rating scale, quality of sleep, global daily activity, WOMAC, improvement of joint mobility according to the Lysholm and Gillquist scores and improvement of pain on a four digit scale.

Secondary ID(s)

Mor01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors