Contact information
Type
Scientific
Primary contact
Prof Joachim Sieper
ORCID ID
Contact details
Charité Campus Benjamin Franklin
Dept of Rheumatology
Hindenburgdamm 30
Berlin
12200
Germany
+49 (0)3084454414
joachim.sieper@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Assessment of efficacy and safety of intraarticular applicated Morphine versus Dexamethasone versus Placebo in gonarthritis in inflammatory rheumatic disease
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Gonarthritis in inflammatory rheumatic disease
Intervention
Single injection of Morphine 3 mg or Dexamethasone 4 mg or Placebo during needle arthroscopy. Rearthroscopy after 7 days.
Intervention type
Drug
Phase
Not Specified
Drug names
Morphine, Dexamethasone
Primary outcome measure
Improvement of VAS pain of at least 20 mm on a 0-100 scale.
Secondary outcome measures
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.
Overall trial start date
01/01/2004
Overall trial end date
01/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
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
Recruitment start date
01/01/2004
Recruitment end date
01/01/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Charité Campus Benjamin Franklin
Berlin
12200
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Benjamin Franklin Campus
Department of Rheumatology
Hindenburgdamm 30
Berlin
12200
Germany
+49 (0)3084454414
joachim.sieper@charite.de
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
German Research Foundation (Deutsche Forschungsgemeinschaft) KFO 100
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list