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

Phase 3

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Placebo; Drug: CS+SG

• Registration Number: NCT01893905
• Lead Sponsor: Tedec-Meiji Farma, S.A.

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 knee.

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 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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2016-12-22
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-25
• Last Update Submitted: 2017-04-25
• Results First Posted: 2017-08-04
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks
CS+SG	CS+SG	Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change in Pain According to VAS (0-100 mm)	24 weeks	VAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).

Trial Locations

Locations (1)

Complejo Hospitalario Universitario La Coruña; 🇪🇸 A Coruña, La Coruña, Spain