The primary objective is to assess whether there is a clinical relevant effectiveness of NSAID compared to Paracetamol over a period consistent with the Dutch guidelines for general practitioners in new consulters with knee OA in general practice.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Aandoeningen van het bewegingsapparaat
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are pain and function measured with the Western Ontario
and McMaster (WOMAC) Osteoarthritis Index calculated with the Knee
Osteoarthritis Outcome Score (KOOS) over a maximum follow-up period of 12
weeks.
Secondary outcome
Secondary outcomes are: 1) patients* perceived pain, 2) Perceive recovery, 3)
patients* quality of life, 4) all direct and indirect medical and patients*
costs, 5) compliance to therapy, 6) co-interventions, and 7) adverse reactions.
Background summary
Based on the lack of trials on comparative effectiveness of NSAIDs versus
Paracetamol in patients consulting the general practitioner (GP) for a new
episode of pain due to knee osteoarthritis (OA), we need to support the Dutch
GP with sufficient knowledge for a convinced choice of type of initial pain
medication. We should know if there is a clinically relevant difference between
the medication and related additional costs.
Study objective
The primary objective is to assess whether there is a clinical relevant
effectiveness of NSAID compared to Paracetamol over a period consistent with
the Dutch guidelines for general practitioners in new consulters with knee OA
in general practice.
Secondary objectives are 1) to identify possible predefined predictors of a
clinical relevant better effectiveness of Diclofenac versus Paracetamol over
the treatment period and 2) when additionally funding is obtained, to assess
the cost-effectiveness of Diclofenac compared to Paracetamol in new consulters
with knee or hip OA in general practice.
Study design
A pragmatic randomized open label trial.
Intervention
One group of patients (n=77) receives Diclofenac (with a maximum daily dose of
150 mg, 3x50 mg) and the other group (n=77) receives Paracetamol (with a
maximum daily dose of 3000 mg, 6x500 mg) for a period of two weeks and if
necessarily another two weeks (conform the Dutch guidelines for general
practitioners).
Study burden and risks
The burden of this study will be minimal because it will evaluate two
medications (Diclofenac versus Paracetamol) that are already prescribed
frequently in the targeted patient population, patients with knee OA.
Subsequently, during the study, patients will fill in a questionnaire for five
times, and assess their daily pain and compliance to the medication in a
diary.
Because of lack of evidence to use the safer Paracetamol, the majority of
patients with (knee) OA in primary care are prescribed NSAIDs to reduce pain,
even if they consult their GP for the first time for pain due to knee OA. OA is
the most frequent joint disease and is a chronic disease causing pain and
disability of especially the knee. Therefore, we evaluate the two medications
in patients with knee OA. Patients* risks are limited and the same as in usual
daily GP care and described in the summary of product characteristics (SPCs) of
involved medication and patients* information leaflets.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Complying to the clinical American College of Rheumatology (ACR) criteria for osteoarthrosis of the knee.
- Have an indication for pain medication.
- A score of 3 or more on the pain severity scale (0-10 scale).
- Patients* aged 45 years or older.
Exclusion criteria
- Contra-indication for NSAID or Paracetamol use
- An arthroplasty or osteotomy of the knee in contralateral or unilateral side.
- Already taking NSAID or paracetamol medication of similar or higher doses as in the study.
- Surgery or major trauma of the affected joint within the previous 6 months.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-004114-28-NL |
| CCMO | NL25624.078.08 |
| Other | NTC 1485 |