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ISRCTN
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ISRCTN72633488
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ClinicalTrials.gov identifier
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Public title
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Intraarticular Application of Opioids versus Glucocorticoids versus Placebo in Gonarthritis
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Assessment of efficacy and safety of intraarticular applicated Morphine versus Dexamethasone versus Placebo in gonarthritis in inflammatory rheumatic disease
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Gonarthritis in inflammatory rheumatic disease
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Participants - inclusion criteria
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1. Age 19-70
2. Gonarthritis with sonographically evident effusion in inflammatory rheumatic disease
3. Visual analogue score (VAS) pain >30 mm
4. Body weight 50-90 kg
5. Written informed consent
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Participants - exclusion criteria
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1. Pregnancy, lactation
2. Severe or opportunistic infection, infection of the knee
3. Malignant diseases
4. Any other severe diseases
5. Platelets <100/nl, Quick <50
6. Significant findings during clinical examination
7. Participation in a clinical trial within 30 days before inclusion
8. Abuse of hard drugs, benzodiacepines, analgesics, alcohol
9. Therapy with anticoagulants
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/01/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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Single injection of Morphine 3 mg or Dexamethasone 4 mg or Placebo during needle arthroscopy. Rearthroscopy after 7 days.
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Primary outcome measure(s)
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Improvement of VAS pain of at least 20 mm on a 0-100 scale.
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Secondary outcome measure(s)
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Impovement of a numeric pain scale, sleep quality, global daily activity, knee mobility with Lysholm and Gilquist Score, Western Ontario McMaster Universities Osteoarthritis (WOMAC) index, relief of pain on a numeric scale from 0-3.
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Sources of funding
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German Research Foundation (Deutsche Forschungsgemeinschaft) KFO 100
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Trial website
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Publications
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Contact name
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Prof
Joachim
Sieper
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Address
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Charité Campus Benjamin Franklin
Dept of Rheumatology
Hindenburgdamm 30
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City/town
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Berlin
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Zip/Postcode
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12200
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Country
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Germany
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Tel
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+49 (0)3084454414
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Fax
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+49 (0)3084454149
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Email
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joachim.sieper@charite.de
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Sponsor
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Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
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Address
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Benjamin Franklin Campus
Department of Rheumatology
Hindenburgdamm 30
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City/town
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Berlin
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Zip/Postcode
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12200
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Country
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Germany
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Tel
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+49 (0)3084454414
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Fax
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+49 (0)3084454149
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Email
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joachim.sieper@charite.de
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Sponsor website:
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http://www.charite.de
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Date applied
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24/08/2005
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Last edited
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06/02/2008
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Date ISRCTN assigned
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21/10/2005
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