Confirmatory study to evaluate the efficacy and safety of chondroitin sulphate and glucosamine sulphate in combination in the treatment of patients with osteoarthritis of the knee compared to placebo.

• Conditions: Knee osteoarthritis.; MedDRA version: 14.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-000444-26-ES
• Lead Sponsor: Tedec-Meiji Farma, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified