SynovitisPhase 3NCT00604539

Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

A Phase 3 study testing Chondroitin sulphate (Condrosan) in people with Synovitis and Osteoarthritis, run by Bioiberica at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Synovitis, Osteoarthritis, Joint Diseases
What is being tested?: Chondroitin sulphate (Condrosan)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 4 sitesCanada
Study dates: Feb 2008to Nov 2009
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

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

Other trials in Canada

About this study

Official title: Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

Conditions: Synovitis, Osteoarthritis, Joint Diseases, Muskuloskeletal Diseases
Being tested: Chondroitin sulphate (Condrosan), Placebo
Keywords: Chondroitin sulphate, Synovitis, Knee osteoarthritis, Magnetic Resonance Imaging
Medical subject headings: Synovitis, Osteoarthritis, Joint Diseases, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00604539
Study group	Role	What they receive
1	Experimental	Chondroitin sulphate Receives: Drug: Chondroitin sulphate (Condrosan)
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: One year

Secondary outcomes (8)

Changes of cartilage volume and subchondral bone lesions
Measured: One year
Pain measured by VAS
Measured: One year
WOMAC index
Measured: One year
SF-36 Health Questionaire
Measured: One year
Assessment of joint swelling, effusion
Measured: One year
Use of rescue medication
Measured: One year
Tolerability
Measured: One year
Adverse events
Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Nov 2009

First posted30 Jan 2008 (estimated)
Study startFeb 2008
Primary completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for SynovitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00604539
Sponsor's protocol ID: CS/IV-SIN-01
Other IDs: CS/IV-SIN-01
Status last verified: Dec 2011
First submitted: 17 Jan 2008
Last updated: 19 Dec 2011
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 15374855
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.
PubMed 15733021
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.
PubMed 16495392
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.
PubMed 7488273
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.
PubMed 10648040
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.
PubMed 16255041
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.
PubMed 10732937
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.
PubMed 15751094
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.
PubMed 8856618
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.
PubMed 15471891
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.
PubMed 16507119
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.
PubMed 12860572
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.
PubMed 15023378
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.
PubMed 21367761

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Synovitis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT00604539
Acronym / sponsor ID: CS/IV-SIN-01
Conditions: Synovitis, Osteoarthritis, Joint Diseases, Muskuloskeletal Diseases
Keywords: Chondroitin sulphate, Synovitis, Knee osteoarthritis, Magnetic Resonance Imaging
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (estimated)
Lead sponsor: BioibericaIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Nov 2009 (actual)
First posted: 30 Jan 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Chondroitin sulphate (Condrosan)Chondroitin sulphate
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chondroitin sulphate (Condrosan)800 mg (two capsules of 400 mg each) taken once a day for one year	Drug	1
PlaceboTwo 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	Drug	2

Primary outcome

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

8 secondary outcomes

Changes of cartilage volume and subchondral bone lesions
Time frame: One year
Pain measured by VAS
Time frame: One year
WOMAC index
Time frame: One year
SF-36 Health Questionaire
Time frame: One year
Assessment of joint swelling, effusion
Time frame: One year
Use of rescue medication
Time frame: One year
Tolerability
Time frame: One year
Adverse events
Time frame: One year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
Background: PubMed 15374855Berthiaume 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.
Background: PubMed 15733021Fajardo M, Di Cesare PE. Disease-modifying therapies for osteoarthritis : current status. Drugs Aging. 2005;22(2):141-61. doi: 10.2165/00002512-200522020-00005.
Background: PubMed 16495392Clegg 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.
Background: PubMed 7488273Hochberg 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.
Background: PubMed 10648040Leeb 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.
Background: PubMed 16255041Loeuille 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.
Background: PubMed 10732937McAlindon 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.
Background: PubMed 15751094Michel 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.
Background: PubMed 8856618Morreale 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.
Background: PubMed 15471891Zhang 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.
Background: PubMed 16507119Raynauld 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.
Background: PubMed 12860572Richy 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.

Related trials for Synovitis

Recruiting
Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
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RecruitingPhase 2
Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)
Tenosynovial Giant Cell Tumor
Not yet recruiting
Transarterial Embolization Versus Sham Procedure in Adults With Treatment-Resistant Inflammatory Arthritis of a Single Large Joint
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Active, not recruitingPhase 3
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Not yet recruitingPhase 2
A Study of DCC-3014 to Evaluate the Efficacy, Safety, and Pharmacokinetics in Subjects With TGCT
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Pierre Pelletier, Prof., Dr. principal investigator

ArthroLab Inc.

Johanne Martel-Pelletier, Prof., Dr. principal investigator

ArthroLab Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chondroitin sulphate (Condrosan) in people with Synovitis and Osteoarthritis, run by Bioiberica at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604539, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2011.