Overview

Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
All
Summary
The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tedec-Meiji Farma, S.A.
Criteria
Inclusion Criteria:

- Patient >= 45 years .

- Primary OA of the knee according to ACR criteria.

- OA radiological grade II-III according to Kellgren and Lawrence.

- Patients with moderate-severe pain.

Exclusion Criteria:

- Patients with clinical significant trauma or surgery in the target knee.

- 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 spondyloarthropathy, mixed
connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel
disease or fibromyalgia.

- 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 (e.g., hepatitis, herpes zoster, HIV positivity) or fungal
infections.

- Clinical diagnosis established of uncontrolled diabetes mellitus.

- Patients with asthma.

- History of hypersensitivity to the active drugs or any excipients of the formulations.