Clinical trial NCT02079727: Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA
Official title: A Multicentre, Comparative, Randomised, Double-blind, Double-dummy Clinical Trial on the Efficacy and Safety of Condrosulf Versus Celebrex and Versus a Placebo in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Condrosulf
Chondroitin sulfate
Celebrex
Knee OA
Knee osteoarthritis
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2014-03-06
Enrollment: 604
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Outpatients of either sex, aged ≥50 years
* Patients affected by primary knee osteoarthritis of the medial or lateral femoro-tibial compartment
* Diagnosis according to the American College of Rheumatology (ACR) criteria
* Kellgren \& Lawrence grade I-III
* Knee osteoarthritis evolving for more than 6 months
* Patients suffering from regular pain and functional disorders from at least 3 months
* Accomplishing a score ≥ 7 of Lequesne's index for the knee osteoarthritis
* Assessing pain on Huskisson's VAS ≥ 50 mm
* With radiography dated less than six months showing a remaining articular joint space
* Without such an axial disorder to justify an osteotomy
* Women taking contraceptive measures if not in menopause
* Women having negative pregnancy test
* Patients able to understand and follow the study protocol
* Patients who have signed the written informed consent for their participation in the clinical trial

Exclusion Criteria:

* With a history of heart attack, ischemic heart disease or cerebrovascular disease (including transient ischemic attacks)
* Having or have had peripheral arterial disease or past surgery orf peripheral arteries
* With a history or currently significat coagulation defect or/and blood dyscrasia
* With high risk of cardiovascular events
* With any acute or chronic infections requiring antimicrobial therapy or serious viral (e.g., hepatitis, HIV positivity) or fungal infections
* With a history of recurrent gastrointestinal ulceration or active inflammatory bowel diseases (e.g., Crohn's disease or ulcerative colitis)
* Having been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
* Having severe liver or kidney disease
* With allergy to Celebrex or any of the other ingredients of Celebrex
* Having had an allergic reaction to sulphonamides
* Having had, as a result of intake of acetylsalicylic acid or other NSAIDs, asthma, nose polyps, severe nose congestion, or an allergic reaction such as itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing
* Presenting lactose intolerance
* Mild or not symptomatic knee osteoarthritis : \< 7 of Lequesne's index,
* Pain on Huskisson's VAS (Visual Analogic Scale) \< 50 mm
* Predominantly femoro-patellar osteoarthritis
* Destructive osteoarthritis of the knee justifying a surgery in the following 6 months
* Osteoarthritis with hydrarthrosis requiring a puncture or an infiltration
* Important genu varum or valgus \>8° (physiological angle including)
* Kellgren \& Lawrence grade IV
* Knee joint surgery in the last 3 months (e.g. chondroscopy, arthroscopy)
* Viscosupplementation, tidal lavage in the last 6 months
* Arthritis and metabolic arthropathies, Paget's illness
* Having consumed: basic treatment of arthritis with SYSADOA, symptomatic slow acting drugs for osteoarthrithis (chondroitin sulphates, glucosamine sulphates, diacerhein, hyaluronic acid and food supplement for joint care) in the last 3 months; treatment with corticoids, by any administration route during the last month; any medication having an influence on pain:
* NSAIDs (nonsteroidal anti-inflammatory drugs) in the 5 days preceding the inclusion (wash-out period considering 5 half-lives of the drug)
* hypnotics, muscle relaxants, anxiolytics, if the intake has started less than 8 days before inclusion
* paracetamol in the 10 hours preceding the inclusion
* Foreseen physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) in the next six months (study period)
* Presenting psychiatric illness hindering the protocol complaince, alcoholism, ongoing or \< 1 year drug dependency
* Pregnant or likely to become it during clinical trial or lactating
* Women having positive pregnancy test
* Having participated in other clinical trials in the month preceding the clinical trial.

Primary outcomes:
measure: Lequesne's Index
timeFrame: Day 1 and Day 182
measure: Pain (VAS in mm)
timeFrame: Day 1 and Day 182
Secondary outcomes:
measure: Lequesne's Index
timeFrame: Day 1, 30, 90 and 182
measure: Pain (VAS in mm)
timeFrame: Day 1, 30, 91 and 182
measure: MCII (minimal clinically important improvement)
timeFrame: Day 1, 30, 91 and 182
measure: PASS (patient acceptable symptom state)
timeFrame: Day 1, 30, 91 and 182
measure: Consumption of Paracetamol
timeFrame: Day 1, 30, 91 and 182
measure: Global efficacy assessment
timeFrame: At Day 30, 91 and 182
measure: Number of adverse events related to the treatments
timeFrame: At Day 30, 91 and 182
measure: Number of drop-outs due to AE (adverse event) related to the treatment
timeFrame: At Day 30, 91 and 182
Other outcomes:
measure: Treatment compliance
timeFrame: Day 1, 30, 91 and 182
Locations:
city: Liege
country: Belgium
facility: Unité d'exploration du metabolism osseux, CHU, Polyclinique universitaires L-Brull
city: Breclav
country: Czech Republic
facility: Interni a revmatologicka ordinace
city: Brno
country: Czech Republic
facility: Ortopedicka Ambulance
city: Ostrava
country: Czech Republic
facility: Vesalion s.r.o.
city: Praha - Krc
country: Czech Republic
facility: Thomayerova nemocnice - Revmatologicke a rehabilitacne oddeleni
city: Praha 2
country: Czech Republic
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czech Republic
facility: Medical Plus
city: Firenze
country: Italy
facility: Azienda Osp. Univ. Di Careggi
city: Lodz
country: Poland
facility: Klinika Zdrowej Kosci
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: ul. Jana III Sobieskiego
country: Poland
facility: SOLB
city: Warszawa
country: Poland
facility: Medica Pro Familia
city: Wiejska
country: Poland
facility: Zdrowie Osteo-Medic
city: Basel
country: Switzerland
facility: Bethesda-Spital
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hôpital Cantonal
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich, Rheumaklinik
Study officials:
affiliation: Unité d'Exploration du Métabolisme Osseux, CHU Centre ville, Polycliniques Universitaires L-Brull, Liège, Belgium
name: Jean-Yves Reginster, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References: