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ISRCTN
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ISRCTN14751911
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ClinicalTrials.gov identifier
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Public title
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Analgesic action of acetaminophen in symptomatic osteoarthritis of the knee: a randomised controlled study
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Scientific title
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Acronym
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Knee study
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Serial number at source
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N/A
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Study hypothesis
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The study was designed to investigate the analgesic effects and mechanisms of acetaminophen (paracetamol) in symptomatic osteoarthritis (OA) of the knee.
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Lay summary
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Ethics approval
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The study was approved by the local ethical committee (Kantonale Ethikkommission, Spezialisierte Unterkommission fur Spezialfa cher) (ref: 343)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Osteoarthritis of the knee
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/11/2001
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Anticipated end date
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31/03/2002
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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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20
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Interventions
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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.
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Primary outcome measure(s)
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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).
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Secondary outcome measure(s)
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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).
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Sources of funding
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1. 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.
2. University Hospital Zurich (Switzerland) - provided the infrastructure
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/16449370
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Contact name
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Dr
Haiko
Sprott
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Address
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Department of Rheumatology and Institute of Physical Medicine
University Hospital Zurich
Gloriastrasse 25
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City/town
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Zurich
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Zip/Postcode
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8091
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Country
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Switzerland
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Tel
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+41 (0)44 2558679
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Fax
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+41 (0)44 2554388
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Email
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haiko.sprott@usz.ch
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Sponsor
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Merck Sharp and Dohme (MSD) (Switzerland)
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Address
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Schaffhauserstrasse 136
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City/town
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Glattbrugg
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Zip/Postcode
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8152
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Country
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Switzerland
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Tel
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+41 (0)1 8287111
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Fax
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+41 (0)1 8287210
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Email
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claude_fischlewitz@merck.com
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Date applied
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09/05/2005
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Last edited
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15/02/2008
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Date ISRCTN assigned
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10/05/2005
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