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Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00244153
Recruitment Status : Unknown
Verified February 2004 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : October 26, 2005
Last Update Posted : September 11, 2006
Information provided by:
Charite University, Berlin, Germany

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

Condition or disease Intervention/treatment Phase
Rheumatic Disease Drug: intraarticular morphine Drug: intraarticular dexamethasone Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Intraarticular Application of Opioids Versus Glucocorticosteroids Versus Placebo in Rheumatoid Arthritis
Study Start Date : June 2004
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00244153

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Contact: Joachim Sieper, Prof. 0049 30 8445 ext 4414
Contact: Hildrun Haibel, MD 0049 30 8445 ext 4414

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Immanuel Krankenhaus Recruiting
Berlin, Germany, 14109
Contact: Andreas Krause, Prof.    0049038050 ext 5293   
Contact: Petra Mertens, MD    0049038050 ext 5293   
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Joachim Sieper, Prof. Charité Campus Benjamin-Franklin, Rheumatology

Layout table for additonal information Identifier: NCT00244153     History of Changes
Other Study ID Numbers: Mor01
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: February 2004

Keywords provided by Charite University, Berlin, Germany:
intraarticular morphine, steroids, arthroscopy

Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics, Opioid
Central Nervous System Depressants
Sensory System Agents