Condition category
Musculoskeletal Diseases
Date applied
09/05/2005
Date assigned
10/05/2005
Last edited
15/02/2008
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

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

  1. 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.

Additional files

Editorial Notes