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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
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00244153
First received: October 25, 2005
Last updated: September 7, 2006
Last verified: February 2004
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244153

Contacts
Contact: Joachim Sieper, Prof. 0049 30 8445 ext 4414 joachim.sieper@charite.de
Contact: Hildrun Haibel, MD 0049 30 8445 ext 4414 hildrun.haibel@charite.de

Locations
Germany
Immanuel Krankenhaus Recruiting
Berlin, Germany, 14109
Contact: Andreas Krause, Prof.     0049038050 ext 5293     a.krause@immanuel.de    
Contact: Petra Mertens, MD     0049038050 ext 5293     p.mertens@immanuel.de    
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Joachim Sieper, Prof. Charité Campus Benjamin-Franklin, Rheumatology
  More Information

No publications provided

ClinicalTrials.gov 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:
Arthritis, Rheumatoid
Rheumatic Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Morphine
BB 1101
Analgesics, Opioid
Anti-Inflammatory Agents
 Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013