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Completed
NCT06623773
Study on Structum® in Adult Patients With Osteoarthritis (TRUST)
Conditions: Osteoarthritis, Knee
Sex: All
Ages: 50 Years – 85 Years
Healthy volunteers: No
Enrollment: 136
Sponsor: Pierre Fabre Medicament
Location: Maciej Dołżyński Bialystok
Summary
Chondroitin sulfate (CS) is a Symptomatic Slow Acting Drugs for OsteoArthritis (SYSADOA) and a natural biomacromolecule belonging to the class of glycosaminoglycans. CS is a major component of the extracellular matrix (ECM), where it constitutes an essential component of proteoglycans.
To this date, no real-world studies have been conducted to precisely describe the burden associated with osteoarthritis (OA) among patients treated with CS.Therefore, an observational, descriptive, prospective, national study will be conducted to describe the burden associated with OA and the quality of life of patients treated with Structum® in Poland.
Eligibility Criteria
Inclusion Criteria:
* Male or female patients aged 50 to 85 years at inclusion
* of knee OA (either a patient newly diagnosed \[at inclusion\] or with history of knee OA) based on at least the following items 1 and/or 2:
1. knee pain lasting for at least 3 months;
2. patient in the active phase of knee OA disease (knee pain score ≥ 40mm at inclusion on the Visual Analog Scale \[VAS\] 0-100 mm);
3. knee radiographs showing knee joint narrowing and/or osteophytes.
* Patients who have been prescribed, for the first time or not, Structum®.
* patient taking any non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics should be on stable dose at least one week before inclusion to the study.
* Patients able to visit the clinic and attend follow-up visits.
* Patients having signed an informed consent form, according to local regulations.
Exclusion Criteria:
* Patients with any ongoing chondroitin sulfate treatment at inclusion or during the last 3 months.
* plasma (in the last 3 months). No glucocorticoids administration in the last 3 months before inclusion. That does not include NSAIDS, paracetamol and other analgesic medications (e.g. tramadol).
* Patients with an artificial knee joint, including unilateral.
* Patients scheduled to undergo knee replacement surgery in the next 6 months.
* Patients with a severe general condition that prevents them from being included in the study as assessed by the investigator.
* Patients participating in interventional trials on investigational drugs at the time of inclusion.
Source: ClinicalTrials.gov (NCT06623773). StuddyBuddy aggregates publicly available trial information.