Knee Osteoarthritis
Conditions
Interventions
Trade Name: DROGLICAN
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Glucosamine Hydrochloride
CAS Number: 66-84-2
Current Spon
Sponsors
BIOIBERICA S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female = 40 years of age with BMI = 40 • Femorotibial knee OA (Uni- or bilateral) o Responding to clinical and radiological criteria of American College of Rheumatology (ACR) o Symptomatic for more than 6 months in the most painful knee o Radiological K&L grade II-III in radiographs from less than 12 months • Moderate-to-severe knee pain: knee pain score evaluated on VAS (0-100) = 40 over the last 24 hours at the inclusion visit (the most painful knee is considered) • Able to follow the instructions of the study • Having signed an informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Related to the OA pathology • Recent trauma (< 1 month) of the knee responsible of the symptomatic knee • Concurrent articular disease interfering with the evaluation of OA and/or pain such as articular dysplasia, aspectic osteonecrosis, acromegaly, Paget’s disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis, etc. • Radiological K&L grade I or IV • Prosthesis in the target knee Related to treatments • Analgesics to manage OA knee pain (Paracetamol, oral NSAIDs, etc.) 24h before inclusion and any follow-up visits • Corticosteroids injection in the target knee in the month preceding inclusion • Hyaluronan injection in the target knee in the last 6 months • Oral corticotherapy = 5mg/day in the last 3 months • Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months • An anticipated need for any OA related medication for the duration of the trial (Corticosteroids or hyaluronan injection, Oral corticotherapy, Arthroscopy) which are forbidden during the trial • Arthroscopy in the last 6 months • Patients with known allergy to CS, GH, or intolerance to rescue treatments (Paracetamol, tramadol and NSAIDs) • Patients with allergy to shellfish Related to associated diseases • Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, tumor, HIV….) • Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee Related to patients • Artialis (study coordinator) or Bioiberica (Sponsor) ‘s employees • Participation to a therapeutic clinical trial in the last 3 months • Under guardianship or judicial protection • Pregnancy, breastfeeding, planned conception • Women without menopause or tubal ligation and without contraception Related to MRI • Unable to receive gadopentetate contrast agent injection because of contraindications: o Acute or chronic severe renal insufficiency (a glomerular filtration rate < 30 mL/min/1.73m2); or o Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. • Known anaphylactic reactions to Gadolinium or related substances • Risk groups for MRI scanning due to magnetic field or contrast agent: Metal in body: Pacemaker / AICD / ICD (coronary defibrillator), Nervus vagus stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insuline pump, Metal implants; f/e screws, prostheses, piercings. • Claustrofibia, or serious mobility problem (Parkinson, tremors)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the evolution of dGEMRIC imaging marker after 6 months of treatment with DROGLICAN®; Secondary Objective: • Use of rescue treatments (Paracetamol, tramadol and oral NSAIDs excluding COX2 inhibitors) • Option: evolution of dGEMRIC imaging marker after 12 months of treatment with DROGLICAN® • Option: evolution of cartilage and bone parameters (volume, thickness, curvature, lesions, etc.) after 6 and 12 months of treatment with DROGLICAN® • Option : evolution of Joint Space Width (JSW)after 12 months of treatment with DROGLICAN® • Tolerance • Compliance ;Primary end point(s): dGEMRIC index; Timepoint(s) of evaluation of this end point: V0 = Inclusion visit V1 = After 6 months of treatment V2 = After 12 months of treatment (option) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: V0 = Inclusion visit V1 = After 6 months of treatment V2 = After 12 months of treatment ; Secondary end point(s): • Option: cartilage/bone parameters (volume, thickness, curvature, lesions, etc.) • Option : radiographic JSW • Adverse events and drop-out • Rescue treatments (Paracetamol, tramadol and oral NSAIDs excluding COX2 inhibitors) • Pill count and compliance assessment by phone call | — |
Countries
Belgium
Contacts
Public ContactClinical Department
ARTIALIS S.A.
Outcome results
None listed