Osteoarthritis, KneePhase 4NCT00556608
Efficacy Study of Intra-articular Hyaluronic Acid in the Knee Osteoarthritis
A Phase 4 study testing Sinovial® (syringe containing sodium hyaluronate solution) and Synvisc® ( syringe containing Hylan G-F 20 solution) in people with Osteoarthritis, Knee, run by IBSA Institut Biochimique SA at 20 sites in 6 countries.
Trial summary
The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Sinovial® (syringe containing sodium hyaluronate solution) and Synvisc® ( syringe containing Hylan G-F 20 solution)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 20 sitesin 6 countries
- Study dates
- Nov 2007to May 2010
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 80 years
- Primary knee OA of the medial or lateral femoro-tibial compartment
- Symptoms for at least 3 months
- Diagnosis according to ACR criteria
- Kellgren \& Lawrence radiological grade 2-3
- Patients who failed to respond sufficiently (not responders) to analgesics and/or NSAIDs taken regularly or responders intolerant to the regular use of analgesics and/or NSAIDs.
Show all 9Show fewer
- Mean WOMAC pain subscore at the target knee >= 40 mm and < 80 mm on a VAS at baseline after wash-out from analgesics/NSAIDs· If bilateral knee OA: definition of the most symptomatic joint at screening based on patient's evaluation and Investigator's clinical judgment and mean WOMAC pain subscore at baseline in the contra-lateral knee < 30 mm
- Written informed consent
- Subject able to understand, co-operative and reliable
Who cannot join
- BMI >= 32 kg/m2
- Secondary (post-traumatic) knee OA
- Predominantly patello-femoral pain/syndrome
- No remaining joint space width
- Symptomatic hip OA or other interfering health condition
- Severe varus/valgus deformity (>15°)
Show all 25Show fewer
- History/present evidence of (target knee): inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropaties; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations.
- Concomitant rheumatic disease
- Significant injury to the target knee in the last 6 months
- Previous joint replacement/arthroplasty (target knee)
- Arthroscopy/osteotomy/surgery in the past 1 year (target knee)
- Any surgery scheduled in the next 6 months
- Venous or lymphatic stasis in the relevant limb
- Skin infection/disease/trauma at the injection site
- Systemic or i.a. (target knee) corticosteroids in the past 3 months
- I.a. corticosteroids (non-target joint) in the past 4 weeks
- Viscosupplementation (target knee) in the past year
- Recently started (in the last 3 months) physical therapy (target knee)
- Recently (in the last 3 months) started therapy or change in dosage of SYSADOAs
- Ongoing anticoagulant therapy
- Chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee
- History of allergy or hypersensitivity to hyaluronic acid or paracetamol or avian proteins
- Participation in a clinical study in the last 3 months
- Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception
- Patients unable to stay in the study for 6 months, non-cooperating, not able to understand
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Italy6 sites
Sezione Dipartimentale a valenza provinciale di Reumatologia - AzUSL 8
Arezzo, 52100
Ospedale Privato Accreditato Nigrisoli
Bologna, 40138
Medicina e Traumatologia dello Sport - AzUSL 2 Lucca
Lucca, 55100
Unità Operativa di Reumatologia - Istituto Ortopedico Gaetano Pini
Milan, 20122
Rheumatology Unit Santa Chiara Hospital
Pisa, 56126
Unità Operativa di Reumatologia - Az. Ospedaliera Universitaria Senese - Policlinico "Le Scotte"
Siena, 53100
Czechia4 sites
Interni hemato-onkologická klinika, Fakultní nemocnice
Brno-Bohunice, 63900
ARTHROMED s.r.o.
Pardubice, 53002
Institute of Rheumatology
Prague, 12850
Centrum léčby pohybového aparátu spol. s.r.o.
Prague, 19061
Slovakia4 sites
F.D. Roosevelt's University Hospital
Banská Bystrica, 975 17
Romjan s.r.o.
Bratislava, 831 03
National Institute of Rheumatic Diseases
Piešťany, 921 12
Rheumatology Clinic, Reumaglobal s.r.o
Trnava, 917 01
Germany3 sites
Orthopädische Universitätsklinik und Poliklinik der RWTH Aachen
Aachen, 52074
Nova clinic
Biberach an der Riss, 88400
Orthopädische Praxis
Stockach, 78333
France2 sites
University Hospital Centre Bois-Guillaume
Bois-Guillaume, 76230
University Hospital Centre of Limoges - Rheumatology Service
Limoges, 87042
Switzerland1 site
Department of Rheumatology and Institute of Physical Medicine - Zurich University
Zurich, 8091
About this study
Official title: Efficacy Evaluation of Intra-articular Hyaluronic Acid (Sinovial®) vs Synvisc® in the Treatment of Symptomatic Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study
The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Sinovial® (syringe containing sodium hyaluronate solution), Synvisc® ( syringe containing Hylan G-F 20 solution)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinovial® (syringe containing sodium hyaluronate solution)Device
Also called Sinovial®: Class III medical device(CE mark n° 0499)
2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.
Synvisc® ( syringe containing Hylan G-F 20 solution)Device
Also called Synvisc®: class III medical device (CE mark n° 0088)
2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.
| Study group | Role | What they receive |
|---|---|---|
| Sinovial | Experimental | 3 intra-articular injections of Sinovial® Receives: Device: Sinovial® (syringe containing sodium hyaluronate solution) |
| Sinvisc | Active comparator | Not described Receives: Device: Synvisc® ( syringe containing Hylan G-F 20 solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in WOMAC pain subscore from baseline
Measured: to week 26
Secondary outcomes (1)
Change in WOMAC OA Index total score and pain, function and stiffness subscores;Change in Lequesne's algofunctional index; Change in global pain (visit assessment); Change in global status by the patient;Change in global status by the Investigator;SPID%
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karel PAVELKA, MD, Principal investigator, Institute of Rheumatology-Na Slupi 4 - 12850 Praha 2 (Czech Republic)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556608
- Sponsor's protocol ID
- 06CZIFCH/Hai06
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2007
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Theiler R, Bruhlmann P. Overall tolerability and analgesic activity of intra-articular sodium hyaluronate in the treatment of knee osteoarthritis. Curr Med Res Opin. 2005 Nov;21(11):1727-33. doi: 10.1185/030079905X65547.
PubMed 16307692Castellacci E, Polieri T. Antalgic effect and clinical tolerability of hyaluronic acid in patients with degenerative diseases of knee cartilage: an outpatient treatment survey. Drugs Exp Clin Res. 2004;30(2):67-73.
PubMed 15272644Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742.
PubMed 14644851Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.
PubMed 11014340Altman RD. Status of hyaluronan supplementation therapy in osteoarthritis. Curr Rheumatol Rep. 2003 Feb;5(1):7-14. doi: 10.1007/s11926-003-0077-6.
PubMed 12590879Lo GH, LaValley M, McAlindon T, Felson DT. Intra-articular hyaluronic acid in treatment of knee osteoarthritis: a meta-analysis. JAMA. 2003 Dec 17;290(23):3115-21. doi: 10.1001/jama.290.23.3115.
PubMed 14679274Wang CT, Lin J, Chang CJ, Lin YT, Hou SM. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. A meta-analysis of randomized controlled trials. J Bone Joint Surg Am. 2004 Mar;86(3):538-45. doi: 10.2106/00004623-200403000-00012.
PubMed 14996880Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD005321. doi: 10.1002/14651858.CD005321.pub2.
PubMed 16625635Recommendations for the registration of drugs used in the treatment of osteoarthritis. Group for the respect of ethics and excellence in science (GREES): osteoarthritis section. Ann Rheum Dis. 1996 Aug;55(8):552-7. doi: 10.1136/ard.55.8.552. No abstract available.
PubMed 8774185Altman R, Brandt K, Hochberg M, Moskowitz R, Bellamy N, Bloch DA, Buckwalter J, Dougados M, Ehrlich G, Lequesne M, Lohmander S, Murphy WA Jr, Rosario-Jansen T, Schwartz B, Trippel S. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results from a workshop. Osteoarthritis Cartilage. 1996 Dec;4(4):217-43. doi: 10.1016/s1063-4584(05)80101-3. No abstract available.
PubMed 11048620Strand V, Kelman A. Outcome measures in osteoarthritis: randomized controlled trials. Curr Rheumatol Rep. 2004 Feb;6(1):20-30. doi: 10.1007/s11926-004-0080-6.
PubMed 14713399Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006 Feb;14(2):154-62. doi: 10.1016/j.joca.2005.09.003. Epub 2005 Oct 19.
PubMed 16242361Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
PubMed 3068365Bellamy N. WOMAC: a 20-year experiential review of a patient-centered self-reported health status questionnaire. J Rheumatol. 2002 Dec;29(12):2473-6. No abstract available.
PubMed 12465137KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
PubMed 13498604
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Intra-articular Hyaluronic Acid (Sinovial®) vs Synvisc® in the Treatment of Symptomatic Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study
- ClinicalTrials.gov ID
- NCT00556608
- Acronym / sponsor ID
- 06CZIFCH/Hai06
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Nov 2007 (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.
The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinovial | Experimental | Device: Sinovial® (syringe containing sodium hyaluronate solution)3 intra-articular injections of Sinovial® |
| Sinvisc | Active comparator | Device: Synvisc® ( syringe containing Hylan G-F 20 solution) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 40 and 80 years
- Primary knee OA of the medial or lateral femoro-tibial compartment
- Symptoms for at least 3 months
- Diagnosis according to ACR criteria
- Kellgren \& Lawrence radiological grade 2-3
Key exclusion criteria (25 listed)
- BMI >= 32 kg/m2
- Secondary (post-traumatic) knee OA
- Predominantly patello-femoral pain/syndrome
- No remaining joint space width
- Symptomatic hip OA or other interfering health condition
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 |
|---|---|---|
| Sinovial® (syringe containing sodium hyaluronate solution)Also: Sinovial®: Class III medical device(CE mark n° 0499)2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week. | Device | Sinovial |
| Synvisc® ( syringe containing Hylan G-F 20 solution)Also: Synvisc®: class III medical device (CE mark n° 0088)2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week. | Device | Sinvisc |
Primary outcome
Improvement in WOMAC pain subscore from baseline
Time frame: to week 26
1 secondary outcome
Change in WOMAC OA Index total score and pain, function and stiffness subscores;Change in Lequesne's algofunctional index; Change in global pain (visit assessment); Change in global status by the patient;Change in global status by the Investigator;SPID%
Time frame: 26 weeks
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 4 Dec 2012.
- Background: PubMed 16307692Theiler R, Bruhlmann P. Overall tolerability and analgesic activity of intra-articular sodium hyaluronate in the treatment of knee osteoarthritis. Curr Med Res Opin. 2005 Nov;21(11):1727-33. doi: 10.1185/030079905X65547.
- Background: PubMed 15272644Castellacci E, Polieri T. Antalgic effect and clinical tolerability of hyaluronic acid in patients with degenerative diseases of knee cartilage: an outpatient treatment survey. Drugs Exp Clin Res. 2004;30(2):67-73.
- Background: PubMed 14644851Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742.
- Background: PubMed 11014340Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.
- Background: PubMed 12590879Altman RD. Status of hyaluronan supplementation therapy in osteoarthritis. Curr Rheumatol Rep. 2003 Feb;5(1):7-14. doi: 10.1007/s11926-003-0077-6.
- Background: PubMed 14679274Lo GH, LaValley M, McAlindon T, Felson DT. Intra-articular hyaluronic acid in treatment of knee osteoarthritis: a meta-analysis. JAMA. 2003 Dec 17;290(23):3115-21. doi: 10.1001/jama.290.23.3115.
- Background: PubMed 14996880Wang CT, Lin J, Chang CJ, Lin YT, Hou SM. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. A meta-analysis of randomized controlled trials. J Bone Joint Surg Am. 2004 Mar;86(3):538-45. doi: 10.2106/00004623-200403000-00012.
- Background: PubMed 16625635Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD005321. doi: 10.1002/14651858.CD005321.pub2.
- Background: PubMed 8774185Recommendations for the registration of drugs used in the treatment of osteoarthritis. Group for the respect of ethics and excellence in science (GREES): osteoarthritis section. Ann Rheum Dis. 1996 Aug;55(8):552-7. doi: 10.1136/ard.55.8.552. No abstract available.
- Background: PubMed 11048620Altman R, Brandt K, Hochberg M, Moskowitz R, Bellamy N, Bloch DA, Buckwalter J, Dougados M, Ehrlich G, Lequesne M, Lohmander S, Murphy WA Jr, Rosario-Jansen T, Schwartz B, Trippel S. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results from a workshop. Osteoarthritis Cartilage. 1996 Dec;4(4):217-43. doi: 10.1016/s1063-4584(05)80101-3. No abstract available.
- Background: PubMed 14713399Strand V, Kelman A. Outcome measures in osteoarthritis: randomized controlled trials. Curr Rheumatol Rep. 2004 Feb;6(1):20-30. doi: 10.1007/s11926-004-0080-6.
- Background: PubMed 16242361Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006 Feb;14(2):154-62. doi: 10.1016/j.joca.2005.09.003. Epub 2005 Oct 19.
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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.
Karel PAVELKA, MD principal investigator
Institute of Rheumatology-Na Slupi 4 - 12850 Praha 2 (Czech Republic)
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sinovial® (syringe containing sodium hyaluronate solution) and Synvisc® ( syringe containing Hylan G-F 20 solution) in people with Osteoarthritis, Knee, run by IBSA Institut Biochimique SA at 20 sites in 6 countries.
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 9 inclusion and 25 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 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy, Czechia, Slovakia, Germany, France and 1 more country. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Improvement in WOMAC pain subscore from baseline (time frame: to week 26). 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 NCT00556608, which also lists 31 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 4 Dec 2012.