Analgesic action of acetaminophen in symptomatic osteoarthritis of the knee: a randomised controlled study
| ISRCTN | ISRCTN14751911 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14751911 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/05/2005
- Registration date
- 10/05/2005
- Last edited
- 15/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Haiko Sprott
Scientific
Scientific
Department of Rheumatology and Institute of Physical Medicine
University Hospital Zurich
Gloriastrasse 25
Zurich
8091
Switzerland
| Phone | +41 (0)44 2558679 |
|---|---|
| haiko.sprott@usz.ch |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Knee study |
| Study objectives | The study was designed to investigate the analgesic effects and mechanisms of acetaminophen (paracetamol) in symptomatic osteoarthritis (OA) of the knee. |
| Ethics approval(s) | The study was approved by the local ethical committee (Kantonale Ethikkommission, Spezialisierte Unterkommission fur Spezialfa cher) (ref: 343) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Acetaminophen (paracetamol), rofecoxib |
| Primary outcome measure | 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 study start date | 01/11/2001 |
| Completion date | 31/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 31/03/2002 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Department of Rheumatology and Institute of Physical Medicine
Zurich
8091
Switzerland
8091
Switzerland
Sponsor information
Merck Sharp and Dohme (MSD) (Switzerland)
Industry
Industry
Schaffhauserstrasse 136
Glattbrugg
8152
Switzerland
| Phone | +41 (0)1 8287111 |
|---|---|
| claude_fischlewitz@merck.com | |
"ROR" |
https://ror.org/009nc9s30 |
Funders
Funder type
Industry
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.
No information available
University Hospital Zurich (Switzerland) - provided the infrastructure
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/06/2006 | Yes | No |
