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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001619-62 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condrosulf (Chondroitin 4&6 sulfate) | Experimental | 1 tablet of Condrosulf 800 mg and 1 capsule of placebo of Celebrex once a day for 182 days |
|
| Placebo (PBO) 800 mg tablet and Placebo (PBO) 200 mg capsule | Placebo Comparator | 1 tablet of PBO of Condrosulf and 1 capsule of PBO of Celebrex, once a day for 182 days |
|
| Celebrex 200 mg capsule | Active Comparator | 1 capsule of 200 mg of Celebrex and 1 tablet of 800 mg placebo of Condrosulf once a day for 182 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chondroitin sulfate | Drug |
|
| |
| celecoxib |
| Measure | Description | Time Frame |
|---|---|---|
| Lequesne's Index | Decrease in the scores of the Lequesne's Index from Day 1 to Day 182. | Day 1 and Day 182 |
| Pain (VAS in mm) | Decrease in the VAS (pain in mm) from Day 1 to Day 182 | Day 1 and Day 182 |
| Measure | Description | Time Frame |
|---|---|---|
| Lequesne's Index | Evolution from Day 1 to Day 30, Day 90 and Day 182 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment compliance | Day 1, 30, 91 and 182 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Yves Reginster, Prof. MD PhD | Unité d'Exploration du Métabolisme Osseux, CHU Centre ville, Polycliniques Universitaires L-Brull, Liège, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité d'exploration du metabolism osseux, CHU, Polyclinique universitaires L-Brull | Liège | Liege | 4020 | Belgium | ||
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002809 | Chondroitin Sulfates |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D002807 | Chondroitin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Drug |
|
|
| placebo | Drug |
|
|
| Day 1, 30, 91 and 182 |
| MCII (minimal clinically important improvement) | Day 1, 30, 91 and 182 |
| PASS (patient acceptable symptom state) | Day 1, 30, 91 and 182 |
| Consumption of Paracetamol | 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. | At Day 30, 91 and 182 |
| Number of adverse events related to the treatments | At Day 30, 91 and 182 |
| Number of drop-outs due to AE (adverse event) related to the treatment | At Day 30, 91 and 182 |
| Ortopedicka Ambulance |
| Brno |
| Czechia |
| Interni a revmatologicka ordinace | Břeclav | Czechia |
| 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 |
| SOLB | Ul. Jana III Sobieskiego | Poland |
| Medica Pro Familia | Warsaw | Poland |
| Zdrowie Osteo-Medic | Wiejska | Poland |
| Bethesda-Spital | Basel | Switzerland |
| HFR Fribourg - Hôpital Cantonal | Fribourg | Switzerland |
| Universitätsspital Zürich, Rheumaklinik | Zurich | Switzerland |
| D012216 |
| Rheumatic Diseases |
| D000096926 |
| Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |