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

Meiji Seika Pharma

Status and phase

Completed

Phase 3

Conditions

Knee Osteoarthritis

Treatments

Drug: Placebo

Drug: CS+SG

Study type

Interventional

Funder types

Industry

Identifiers

NCT01893905

2013-000444-26 (EudraCT Number)

TM-CS+SG /301

Details and patient eligibility

About

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.

Full description

The purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. Eligible patients will be randomized 1:1 and the treatments will be administered for 24 weeks. Clinical efficacy at the end of treatment will be evaluated. Safety will be evaluated through adverse events recoding during the study period.

Enrollment

158 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.