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

NCT ID: NCT01893905

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-08-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CS+SG

Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks

Group Type: EXPERIMENTAL

CS+SG

Intervention Type: DRUG

Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.

Placebo

Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.

Interventions

CS+SG

Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.

Intervention Type: DRUG

Placebo

Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.

Intervention Type: DRUG

Other Intervention Names

Chondroitin sulfate+glucosamine sulfate; Placebo chondroitin sulfate+glucosamine sulfate

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tedec-Meiji Farma, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

FJ Blanco, M.D.

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario La Coruña

Locations

Complejo Hospitalario Universitario La Coruña

A Coruña, La Coruña, Spain

Countries

Spain

References

Roman-Blas JA, Castaneda S, Sanchez-Pernaute O, Largo R, Herrero-Beaumont G; CS/GS Combined Therapy Study Group. 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. Arthritis Rheumatol. 2017 Jan;69(1):77-85. doi: 10.1002/art.39819.

Reference Type: DERIVED

PMID: 27477804 (View on PubMed)

Other Identifiers

2013-000444-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TM-CS+SG /301

Identifier Type: -

Identifier Source: org_study_id