The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
Recruiting
Phase 3
Interventional Study
Osteoarthritis, Knee
Osteoarthritis, Hip
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 45 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,410 (estimated)
- Sponsor
- Sint Maartenskliniek · Other
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About This Trial
The goal of this clinical trial is to evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on the incidence of first occurrence of knee or hip replacement. The main question it aims to answer is:
Does colchicine lower the number of knee or hip replacements in participants with osteoarthritis?
Researchers will compare…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* clinical diagnosis of knee or hip OA
* 45 ≤ age ≤ 80 (upper age limit is similar to that in the LoDoCo2 trial and takes in consideration the lower number of joint replacements in people older than 80 years)
* documented radiographic changes typical for advanced knee/hip OA (Ke…
Contacts