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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.
ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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.

Eligibility Criteria

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov 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:
Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Dexamethasone
Morphine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents