Condition category
Musculoskeletal Diseases
Date applied
24/08/2005
Date assigned
21/10/2005
Last edited
06/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.charite.de

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes