Contact information
Type
Scientific
Primary contact
Dr Haiko Sprott
ORCID ID
Contact details
Department of Rheumatology and Institute of Physical Medicine
University Hospital Zurich
Gloriastrasse 25
Zurich
8091
Switzerland
+41 (0)44 2558679
haiko.sprott@usz.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Knee study
Study hypothesis
The study was designed to investigate the analgesic effects and mechanisms of acetaminophen (paracetamol) in symptomatic osteoarthritis (OA) of the knee.
Ethics approval
The study was approved by the local ethical committee (Kantonale Ethikkommission, Spezialisierte Unterkommission fur Spezialfa cher) (ref: 343)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Osteoarthritis of the knee
Intervention
After washout of earlier OA medications, patients were randomly allocated into two groups treated with either acetaminophen up to 4 g per day (n = 10, age 60-77 years) or rofecoxib 25 mg per day (n = 10, age 48-80 years) for 3 months.
Intervention type
Drug
Phase
Not Specified
Drug names
Acetaminophen (paracetamol), rofecoxib
Primary outcome measures
The functional status of the knee joint was assessed by the Western Ontario McMaster Universities Osteoarthritis (WOMAC) questionnaire in German. Visits and measurements were scheduled upon entry (T0), month 1 (T1) and month 3 (T3).
Secondary outcome measures
The intensity of joint pain was evaluated by 100-mm visual analogue scale (VAS) at rest. Visits and measurements were scheduled upon entry (T0), month 1 (T1) and month 3 (T3).
Overall trial start date
01/11/2001
Overall trial end date
31/03/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Patients and healthy subjects: 20 patients fulfilled the American College of Rheumatology criteria for knee OA accompanied with joint pain (visual analogue scale [VAS] ≥60) were recruited to the study. For control, blood from 20 age and gender-matched healthy subjects was obtained from a local blood bank, the Blutspenderdienst Zürich. All patients signed the informed consent.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Secondary OA as a consequence of inflammation, gout, pseudogout or tumour
2. Kidney insufficiency
3. OA-influencing concomitant diseases
4. Drug medication with opioids
Recruitment start date
01/11/2001
Recruitment end date
31/03/2002
Locations
Countries of recruitment
Switzerland
Trial participating centre
Department of Rheumatology and Institute of Physical Medicine
Zurich
8091
Switzerland
Sponsor information
Organisation
Merck Sharp and Dohme (MSD) (Switzerland)
Sponsor details
Schaffhauserstrasse 136
Glattbrugg
8152
Switzerland
+41 (0)1 8287111
claude_fischlewitz@merck.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Merck Sharp and Dohme (MSD) (Switzerland) - gave a Medical School Grant in 2001 to perform the study, and provided the drug Vioxx (rofecoxib). The acetaminophen drugs and the other research costs were paid for from the grant.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University Hospital Zurich (Switzerland) - provided the infrastructure
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/16449370
Publication citations
-
Results
Shen H, Sprott H, Aeschlimann A, Gay RE, Michel BA, Gay S, Sprott H, Analgesic action of acetaminophen in symptomatic osteoarthritis of the knee., Rheumatology (Oxford), 2006, 45, 6, 765-770, doi: 10.1093/rheumatology/kei253.