Knee osteoarthritis. MedDRA version: 14.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: Asociación de condroitín sulfato y glucosamina sulfato
Product Code: CS+SG
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: CHONDROITIN SULPHATE SODIUM
Current Sponsor
Sponsors
Tedec-Meiji Farma, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient aged at 45 or more years old, of both sexes. Primary knee OA according to ACR criteria. Osteoarthritis radiological grade II-III according to Kellgren and Lawrence scale. Patients with moderate-severe pain (from 40-80 mm) in Visual Analogue Scale (VAS) during last week of the most symptomatic knee. Patient able to understand and follow study procedures, also to willingness to adhere to treatment. Patient who agrees to participate in the study by giving his/her written 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 314 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Overweight (body mass index greater than or equal 35). Pregnant or lactating women. Women of child-bearing age not using effective contraception. Predominant patellofemoral disease. Patients with clinical significant trauma or surgery in the target knee. Administration of NSAIDs within the 14 days prior to the inclusion in the study. Administration of any intra-articular treatment, glucosamine sulphate, chondroitin sulphate and/or diacerein within the 3 months prior to their inclusion in the study. Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy. Pain in other parts of the body greater than the knee pain that could interfere with the evaluation. Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral or fungal infections. Clinical diagnosis established of uncontrolled diabetes mellitus, with fasting glucose greater than 126 mg. Patients with asthma. Any pathology that could interfere with the administration or assessment. History of hypersensitivity to any excipients or pharmacological product. Patients awaiting surgery. Patients awaiting disablement assessment. Previous participation in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of a combination of chondroitin sulphate and glucosamine sulphate manufactured by Tedec-Meiji Farma, S.A. compared with placebo in patients with osteoarthritis of the knee.;Secondary Objective: To assess the safety of treatment.;Primary end point(s): Reduction of pain in Visual Analogue Scale (0-100 mm) at the end of treatment. Success will be considered as an absolute difference of 10 points at the end of treatment between chondroitin sulfate+glucosamine sulfate group and placebo group.;Timepoint(s) of evaluation of this end point: 6 months (end of treatment period). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): OMERACT-OARSI responder criteria (and corresponding subscales), WOMAC score with the use of 0-100 mm VAS, Global Investigator Assessment and the consumption of rescue medication.;Timepoint(s) of evaluation of this end point: 1, 3 and 6 months during treatment. | — |
Countries
Spain
Contacts
Public ContactDepartamento Investigación Clínica
Tedec-Meiji Farma, S.A.
Outcome results
None listed