Phase 3
Completed N=158
Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
Source: ClinicalTrials.gov NCT01893905 ↗Enrolled (actual)
158
Serious AEs
2.5%
Results posted
Aug 2017
Primary outcomePrimary: Change in Pain According to VAS (0-100 mm) — -11.86; -20.57 units on a scale — p=<0.0307
◆ Published Evidence
Highly cited
123citations · ~14 / year
Combined Treatment With Chondroitin Sulfate and Glucosamine Sulfate Shows No Superiority Over Placebo for Reduction of Joint Pain and Functional Impairment in Patients With Knee Osteoarthritis: A Six-Month Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
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.
Linked Publications
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Combined Treatment With Chondroitin Sulfate and Glucosamine Sulfate Shows No Superiority Over Placebo for Reduction of Joint Pain and Functional Impairment in Patients With Knee Osteoarthritis: A Six-Month Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain According to VAS (0-100 mm) |
-11.86; -20.57 | <0.0307 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01893905) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.