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

• ClinicalTrials.gov Identifier: NCT01893905
• Recruitment Status: Completed
• First Posted: July 9, 2013
• Results First Posted: August 4, 2017
• Last Update Posted: August 4, 2017
• Sponsor: Tedec-Meiji Farma, S.A.
• Information provided by (Responsible Party): Tedec-Meiji Farma, S.A.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Drug: CS+SG; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondroitin Sulfate and Glucosamine Sulfate in Combination Versus Placebo in Patients With Osteoarthritis of the Knee
• Study Start Date: June 2013
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: CS+SG; Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks	Drug: CS+SG; Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.; Other Name: Chondroitin sulfate+glucosamine sulfate
Placebo Comparator: Placebo; Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks	Drug: Placebo; Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.; Other Name: Placebo chondroitin sulfate+glucosamine sulfate

Outcome Measures

Primary Outcome Measures :

1. Change in Pain According to VAS (0-100 mm) [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Spain

Complejo Hospitalario Universitario La Coruña

A Coruña, La Coruña, Spain, 15006

Sponsors and Collaborators

Tedec-Meiji Farma, S.A.

Investigators

• Principal Investigator: FJ Blanco, M.D.; Complejo Hospitalario Universitario La Coruña

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Roman-Blas JA, Castañeda S, Sánchez-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. Erratum in: Arthritis Rheumatol. 2017 Oct;69(10 ):2080.

• Responsible Party: Tedec-Meiji Farma, S.A.
• ClinicalTrials.gov Identifier: NCT01893905
• Other Study ID Numbers: TM-CS+SG /301; 2013-000444-26 ( EudraCT Number )
• First Posted: July 9, 2013
• Results First Posted: August 4, 2017
• Last Update Posted: August 4, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases