Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis

NCT00244153 | Unknown Phase 1

• 1 other identifier: Mor01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 or placebo in knee arthritis

Conditions

Rheumatic Disease

Keywords

intraarticular morphine, steroids, arthroscopy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

intraarticular morphine DRUG

intraarticular dexamethasone DRUG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Immanuel Krankenhaus

Berlin, 14109, Germany

RECRUITING

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joachim Sieper, Prof.

  Charité Campus Benjamin-Franklin, Rheumatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joachim Sieper, Prof.

CONTACT

0049 30 8445; joachim.sieper@charite.de

Hildrun Haibel, MD

CONTACT

0049 30 8445; hildrun.haibel@charite.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 26, 2005
• Study Start: June 1, 2004
• Study Completion: August 1, 2007
• Last Updated: September 11, 2006

Record last verified: 2004-02

Locations

DE (1)