Osteoarthritis, KneePhase 3NCT00139295
Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee
A Phase 3 study testing Hylastan in people with Osteoarthritis, Knee, run by Genzyme, a Sanofi Company at 24 sites in 5 countries.
Trial summary
This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Hylastan
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 24 sitesin 5 countries
- Study dates
- Oct 2004to Sep 2007
- 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
- Diagnosed with OA of the knee
- Have tried but not been sufficiently helped by conservative treatment, such as weight reduction and pain medications
Who cannot join
- Prior or concomitant treatments that would impede measurement of safety and efficacy
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States15 sites
Capstone Clinical Trials, Inc
Birmingham, Alabama, 35209
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
Midwest Orthopedics at Rush University Medical Center
Chicago, Illinois, 60612
Orthopaedic Specialties of Tampa Bay
Clearwater, Florida, 33756
Coastal Orthopedic Associates
Conway, South Carolina, 29526
Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, 21702
Orthopedic Center for Joint Replacement and Sports
Grants Pass, Oregon, 97527
Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research
Lexington, Kentucky, 40509
Hope Research Institute, LLC
Phoenix, Arizona, 85050
Rockford Health Physicians
Rockford, Illinois, 61103
Unlimited Research
San Antonio, Texas, 78217
Arthritis Northwest
Seattle, Washington, 98166
Orthopedic Specialists of Louisiana
Shreveport, Louisiana, 71101
Tucson Orthopedic Institute, PC
Tucson, Arizona, 85712
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610
France3 sites
Clinique du Sport
Mérignac, 33700
Centre Hospitalier Lyon-Sud, Service de Rhumatologie
Pierre-Bénite, 69495
CHU Hôpital Trousseau Service de Rhumatologie
Tours, 37044
United Kingdom3 sites
Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department
Leytonstone, London, E11 1NR
Maidstone General Hospital & Tunbridge Wells NHS Trust
Maidstone, Kent, ME16 9QQ
Southampton General Hospital, MRC Environmental Epidemiology Unit
Southampton, Hampshire, SO16 6YD
Germany2 sites
St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis
Heidelberg, 69121
Orthopaedische Gemeinschaftspraxis
Weyhe-Kirchweyhe, 28844
About this study
Official title: Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee
This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Hylastan
- Keywords
- musculoskeletal, osteoarthritis of the knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HylastanDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startOct 2004
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139295
- Sponsor's protocol ID
- AVS00103
- Status last verified
- Feb 2014
- First submitted
- 29 Aug 2005
- Last updated
- 5 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00139295
- Acronym / sponsor ID
- AVS00103
- Conditions
- Osteoarthritis, Knee
- Keywords
- musculoskeletal, osteoarthritis of the knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Sep 2007 (actual)
- First posted
- 31 Aug 2005 (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.
This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with OA of the knee
- Have tried but not been sufficiently helped by conservative treatment, such as weight reduction and pain medications
Key exclusion criteria (1 listed)
- Prior or concomitant treatments that would impede measurement of safety and efficacy
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 |
|---|---|---|
| Hylastan | Device | – |
Primary outcome
pain relief
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 5 Feb 2014.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hylastan in people with Osteoarthritis, Knee, run by Genzyme, a Sanofi Company at 24 sites in 5 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 2 inclusion and 1 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 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, France, United Kingdom, Germany, 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. 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?
pain relief. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2014.