The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4\&6 sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as active comparator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
604
Unité d'exploration du metabolism osseux, CHU, Polyclinique universitaires L-Brull
Liège, Liege, Belgium
Ortopedicka Ambulance
Brno, Czechia
Interni a revmatologicka ordinace
Břeclav, Czechia
Lequesne's Index
Decrease in the scores of the Lequesne's Index from Day 1 to Day 182.
Time frame: Day 1 and Day 182
Pain (VAS in mm)
Decrease in the VAS (pain in mm) from Day 1 to Day 182
Time frame: Day 1 and Day 182
Lequesne's Index
Evolution from Day 1 to Day 30, Day 90 and Day 182
Time frame: Day 1, 30, 90 and 182
Pain (VAS in mm)
Evolution of the pain on VAS (in mm) from Day 1 to Day 30, Day 91 and Day 182
Time frame: Day 1, 30, 91 and 182
MCII (minimal clinically important improvement)
Time frame: Day 1, 30, 91 and 182
PASS (patient acceptable symptom state)
Time frame: Day 1, 30, 91 and 182
Consumption of Paracetamol
Time frame: Day 1, 30, 91 and 182
Global efficacy assessment
Global efficacy assessed by the patient and the Investigator by means of a semi-quantitative verbal scale.
Time frame: At Day 30, 91 and 182
Number of adverse events related to the treatments
Time frame: At Day 30, 91 and 182
Number of drop-outs due to AE (adverse event) related to the treatment
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Vesalion s.r.o.
Ostrava, Czechia
Revmatologicky ustav
Prague, Czechia
Thomayerova nemocnice - Revmatologicke a rehabilitacne oddeleni
Praha - Krc, Czechia
Medical Plus
Uherské Hradiště, Czechia
Azienda Osp. Univ. Di Careggi
Florence, Italy
Klinika Zdrowej Kosci
Lodz, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, Poland
...and 6 more locations
Time frame: At Day 30, 91 and 182