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Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2004 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: October 25, 2005
Last updated: September 7, 2006
Last verified: February 2004

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 Intervention Phase
Rheumatic Disease
Drug: intraarticular morphine
Drug: intraarticular dexamethasone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Intraarticular Application of Opioids Versus Glucocorticosteroids Versus Placebo in Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: June 2004
Estimated Study Completion Date: August 2007
  Show Detailed Description


Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00244153

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

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
Principal Investigator: Joachim Sieper, Prof. Charité Campus Benjamin-Franklin, Rheumatology
  More Information

No publications provided Identifier: NCT00244153     History of Changes
Other Study ID Numbers: Mor01
Study First Received: October 25, 2005
Last Updated: September 7, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Rheumatic Diseases
Connective Tissue Diseases
Musculoskeletal Diseases
Analgesics, Opioid
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 20, 2014