NCT00604539

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

1.8 years

First QC Date

January 17, 2008

Last Update Submit

December 16, 2011

Conditions

SynovitisOsteoarthritisJoint DiseasesMuskuloskeletal Diseases

Keywords

Chondroitin sulphateSynovitisKnee osteoarthritisMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • 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

    One year

Secondary Outcomes (8)

  • Changes of cartilage volume and subchondral bone lesions

    One year

  • Pain measured by VAS

    One year

  • WOMAC index

    One year

  • SF-36 Health Questionaire

    One year

  • Assessment of joint swelling, effusion

    One year

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Chondroitin sulphate

Drug: Chondroitin sulphate (Condrosan)

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Chondroitin sulphate (Condrosan)DRUG

800 mg (two capsules of 400 mg each) taken once a day for one year

1
PlaceboDRUG

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

2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Inst. De Rhumatologie

Montreal, Quebec, H2L 1S6, Canada

Location

Groupe de recherche en rhumatologie et maladies osseuses

Ste-Foy, Quebec, G1V 3M7, Canada

Location

Centre de rhumatologie St-Louis

Ste-Foy, Quebec, G1W 4R4, Canada

Location

Centre de recherche musculo-squelettique

Trois-Rivières, Quebec, G8A 1Y2, Canada

Location

Related Publications (14)

  • Berthiaume MJ, Raynauld JP, Martel-Pelletier J, Labonte 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. doi: 10.1136/ard.2004.023796. Epub 2004 Sep 16.

    PMID: 15374855BACKGROUND

  • Fajardo M, Di Cesare PE. Disease-modifying therapies for osteoarthritis : current status. Drugs Aging. 2005;22(2):141-61. doi: 10.2165/00002512-200522020-00005.

    PMID: 15733021BACKGROUND

  • 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. doi: 10.1056/NEJMoa052771.

    PMID: 16495392BACKGROUND

  • 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. doi: 10.1002/art.1780381104.

    PMID: 7488273BACKGROUND

  • 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.

    PMID: 10648040BACKGROUND

  • 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. doi: 10.1002/art.21373.

    PMID: 16255041BACKGROUND

  • 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. doi: 10.1001/jama.283.11.1469.

    PMID: 10732937BACKGROUND

  • 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. doi: 10.1002/art.20867.

    PMID: 15751094BACKGROUND

  • 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.

    PMID: 8856618BACKGROUND

  • 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. doi: 10.1136/ard.2004.028886. Epub 2004 Oct 7.

    PMID: 15471891BACKGROUND

  • 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. doi: 10.1186/ar1875. Epub 2005 Dec 30.

    PMID: 16507119BACKGROUND

  • 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. doi: 10.1001/archinte.163.13.1514.

    PMID: 12860572BACKGROUND

  • Uebelhart D, Malaise M, Marcolongo R, de Vathaire 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. doi: 10.1016/j.joca.2004.01.004.

    PMID: 15023378BACKGROUND

  • Wildi LM, Raynauld JP, Martel-Pelletier J, Beaulieu A, Bessette L, Morin F, Abram F, Dorais M, Pelletier JP. Chondroitin sulphate reduces both cartilage volume loss and bone marrow lesions in knee osteoarthritis patients starting as early as 6 months after initiation of therapy: a randomised, double-blind, placebo-controlled pilot study using MRI. Ann Rheum Dis. 2011 Jun;70(6):982-9. doi: 10.1136/ard.2010.140848. Epub 2011 Mar 1.

    PMID: 21367761RESULT

MeSH Terms

Conditions

SynovitisOsteoarthritisJoint DiseasesOsteoarthritis, Knee

Interventions

Chondroitin

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesArthritisRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Jean-Pierre Pelletier, Prof., Dr.

    ArthroLab Inc.

    PRINCIPAL INVESTIGATOR

  • Johanne Martel-Pelletier, Prof., Dr.

    ArthroLab Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 30, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2009

Last Updated

December 19, 2011

Record last verified: 2011-12

Locations

CA(4)