Status:
COMPLETED
Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
Lead Sponsor:
Tedec-Meiji Farma, S.A.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief 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 kn...
Detailed 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 mode...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01893905
Start Date
June 1 2013
End Date
August 1 2014
Last Update
August 4 2017
Active Locations (1)
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1
Complejo Hospitalario Universitario La Coruña
A Coruña, La Coruña, Spain, 15006