Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee - Full Text View

Sponsored by:	Bioiberica
Information provided by:	Bioiberica
ClinicalTrials.gov Identifier:	NCT00604539

Purpose

The purpose of this study is to determine the effect of a chondroitin sulphate conventional treatment on the degree of severity of synovitis, as measured by magnetic resonance in patients with knee OA with clinical synovitis.

Condition	Intervention	Phase
Synovitis Osteoarthritis Joint Diseases Muskuloskeletal Diseases	Drug: Chondroitin sulphate (Condrosan) Drug: Placebo	Phase III

MedlinePlus related topics: Joint Disorders Osteoarthritis

Drug Information available for: Chondroitin Chondroitin sulfates Translagen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

Further study details as provided by Bioiberica:

Primary Outcome Measures:

Evaluation of the change in the severity of synovitis measured by MRI according to the modified methods of Loeuille et al. after chondroitin sulphate treatment in patients with knee OA and clinical signs of synovitis [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes of cartilage volume and subchondral bone lesions [ Time Frame: One year ] [ Designated as safety issue: No ]
Pain measured by VAS [ Time Frame: One year ] [ Designated as safety issue: No ]
WOMAC index [ Time Frame: One year ] [ Designated as safety issue: No ]
SF-36 Health Questionaire [ Time Frame: One year ] [ Designated as safety issue: No ]
Assessment of joint swelling, effusion [ Time Frame: One year ] [ Designated as safety issue: No ]
Use of rescue medication [ Time Frame: One year ] [ Designated as safety issue: No ]
Tolerability [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	February 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Chondroitin sulphate	Drug: Chondroitin sulphate (Condrosan) 800 mg (two capsules of 400 mg each) taken once a day for one year
2: Placebo Comparator	Drug: Placebo Two placebo capsules taken once a day for six months followed by an additional six month treatment of 800 mg (two capsules of 400 mg of Chondroitin sulphate each) taken once a day

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary OA of the knee according to ACR with synovitis criteria (warmth, swelling or effusion);
OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray;
VAS of pain while walking ≥40 mm.

Exclusion Criteria:

Known allergy to chondroitin sulphate;
Progressive or serious pathologies (cancer, AIDS,...);
Other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis;
Corticosteroids (oral, injectable), indomethacin, therapeutic dose of glucosamine or chondroitin sulphate during the 12 weeks preceding inclusion;
Hyaluronic Acid (intra-articular pathway) during the 26 weeks preceding inclusion;
Radioactive synovectomy during the 12 weeks preceding inclusion;
If the patient is receiving NSAID at baseline (D0), it should be maintained at a stable dosage as much as possible from D0 to D180. In the open phase of the study (D180 to D360), NSAID will also be allowed as rescue medication along with acetaminophen.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604539

Locations

Canada, Quebec
Centre de rhumatologie St-Louis
Ste-Foy, Quebec, Canada, G1W 4R4
Groupe de recherche en rhumatologie et maladies osseuses
Ste-Foy, Quebec, Canada, G1V 3M7
Centre de recherche musculo-squelettique
Trois-Rivieres, Quebec, Canada, G8A 1Y2
Inst. De Rhumatologie
Montréal, Quebec, Canada, H2L 1S6

Sponsors and Collaborators

Bioiberica

Investigators

Principal Investigator:	Jean-Pierre Pelletier, Prof., Dr.	ARTHROLAB INC.
Principal Investigator:	Johanne Martel-Pelletier, Prof., Dr.	ARTHROLAB INC.

More Information

Publications:

Berthiaume MJ, Raynauld JP, Martel-Pelletier J, Labonté F, Beaudoin G, Bloch DA, Choquette D, Haraoui B, Altman RD, Hochberg M, Meyer JM, Cline GA, Pelletier JP. Meniscal tear and extrusion are strongly associated with progression of symptomatic knee osteoarthritis as assessed by quantitative magnetic resonance imaging. Ann Rheum Dis. 2005 Apr;64(4):556-63. Epub 2004 Sep 16.

Fajardo M, Di Cesare PE. Disease-modifying therapies for osteoarthritis : current status. Drugs Aging. 2005;22(2):141-61. Review.

Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006 Feb 23;354(8):795-808.

Hochberg MC, Altman RD, Brandt KD, Clark BM, Dieppe PA, Griffin MR, Moskowitz RW, Schnitzer TJ. Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee.American College of Rheumatology. Arthritis Rheum. 1995 Nov;38(11):1541-6.

Leeb BF, Schweitzer H, Montag K, Smolen JS. A metaanalysis of chondroitin sulfate in the treatment of osteoarthritis. J Rheumatol. 2000 Jan;27(1):205-11.

Loeuille D, Chary-Valckenaere I, Champigneulle J, Rat AC, Toussaint F, Pinzano-Watrin A, Goebel JC, Mainard D, Blum A, Pourel J, Netter P, Gillet P. Macroscopic and microscopic features of synovial membrane inflammation in the osteoarthritic knee: correlating magnetic resonance imaging findings with disease severity. Arthritis Rheum. 2005 Nov;52(11):3492-501.

McAlindon TE, LaValley MP, Gulin JP, Felson DT. Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and meta-analysis. JAMA. 2000 Mar 15;283(11):1469-75. Review.

Michel BA, Stucki G, Frey D, De Vathaire F, Vignon E, Bruehlmann P, Uebelhart D. Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: a randomized, controlled trial. Arthritis Rheum. 2005 Mar;52(3):779-86.

Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol. 1996 Aug;23(8):1385-91.

Zhang W, Doherty M, Arden N, Bannwarth B, Bijlsma J, Gunther KP, Hauselmann HJ, Herrero-Beaumont G, Jordan K, Kaklamanis P, Leeb B, Lequesne M, Lohmander S, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Swoboda B, Varatojo R, Verbruggen G, Zimmermann-Gorska I, Dougados M; EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2005 May;64(5):669-81. Epub 2004 Oct 7. Review.

Raynauld JP, Martel-Pelletier J, Berthiaume MJ, Beaudoin G, Choquette D, Haraoui B, Tannenbaum H, Meyer JM, Beary JF, Cline GA, Pelletier JP. Long term evaluation of disease progression through the quantitative magnetic resonance imaging of symptomatic knee osteoarthritis patients: correlation with clinical symptoms and radiographic changes. Arthritis Res Ther. 2006;8(1):R21. Epub 2005 Dec 30.

Richy F, Bruyere O, Ethgen O, Cucherat M, Henrotin Y, Reginster JY. Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: a comprehensive meta-analysis. Arch Intern Med. 2003 Jul 14;163(13):1514-22.

Uebelhart D, Malaise M, Marcolongo R, DeVathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis Cartilage. 2004 Apr;12(4):269-76.

Responsible Party:	Bioibérica S.A. ( Dr. Josep Vergés, Scientific Medical Director )
Study ID Numbers:	CS/IV-SIN-01, CS/IV-SIN-01
Study First Received:	January 17, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00604539
Health Authority:	Canada: Health Canada

Keywords provided by Bioiberica:

Chondroitin sulphate
Synovitis
Knee osteoarthritis
Magnetic Resonance Imaging

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Arthritis

Joint Diseases
Synovitis
Rheumatic Diseases
Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009