KNEE OSTEOARTHRITIS MedDRA version: 14.1 Level: LLT Classification code 10003416 Term: Arthrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: DROGLICAN 200mg/250mg hard capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: GLUCOSAMINE HYDROCHLORIDE
Other descriptive name: GLUCOSAMINE HYDROCHLORIDE
Concentration unit:
Sponsors
BIOIBERICA, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of primary OA of the knee according to the ACR criteria -Patients with OA of radiological stages II or III according to Kellgren and Lawrence -Patients with moderate-to-severe knee pain: WOMAC pain score > 301 at the Inclusion visit Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 560 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 560
Exclusion criteria
Exclusion criteria: -Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget’s disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease -Subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure -Subjects with any significant diseases or conditions, including emotional or psychiatric disorders or substance abuse that, in the opinion of the Investigator, are likely to alter the course of OA or the subject’s ability to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to show that the combination treatment CS/GH has comparable efficacy to CE in pain reduction from baseline to 6 months of treatment (WOMAC pain subscale) in knee OA patients with moderate to severe pain. ;Secondary Objective: Secondary objectives include the comparison of other outcomes related to signs and symptoms of knee OA and to compare the safety and tolerability of both treatment groups.;Primary end point(s): Change from baseline (mean decrease) in WOMAC Pain subscale after 6 months of treatment.;Timepoint(s) of evaluation of this end point: Screening visit, inclusion visit, 30-days follow-up visit, 60-days follow-up visit, 120-days follow-up visit and final visit (180-days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy outcomes -Change from baseline (mean decrease) in both WOMAC Stiffness Subscale and Function Subscale after 6 months of treatment. -Change from baseline (Mean decrease) in pain according to Huskisson’s VAS after 6 months of treatment. -OARSI set of responder criteria. -Assessment of the presence or absence of joint swelling and/or effusion. -Consumption of rescue medication. -Patient’s global assessment of disease activity. -Investigator’s global assessment of disease activity. -Patient’s global assessment of response to therapy. -Investigator’s global assessment of response to therapy. -Health status according to EuroQoL-5D. Safety outcomes -The tolerability assessment of study treatments will be carried out in accordance with the number of patients who require discontinuation of the study medication because of AE -Monitoring of the laboratory parameters that will include haematology profile, SR, CRP, liver function test (AST, ALT, bilirubin), renal function test (urea, creatinine, electrolytes), glucose, insulin, partial thromboplastin, total cholesterol, LDL, HDL, triglycerides after a 12-hour fast and urinalyses. -Additional safety parameters would include the examination of vital signs such as blood pressure and BMI and the physical examination. ;Timepoint(s) of evaluation of this end point: Inclusion visit, follow-up visits and final visit. | — |
Countries
Poland, Spain
Contacts
Public ContactMARTA HERRERO
BIOIBERICA, S.A.
Outcome results
None listed