Osteoarthritis, HipPhase 3NCT00131326
A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip
A Phase 3 study testing Synvisc (hylan G-F 20) in people with Osteoarthritis, Hip and Musculoskeletal Diseases, run by Genzyme, a Sanofi Company at 32 sites in United States.
Trial summary
This is a clinical study to investigate the safety and efficacy of Synvisc and Depo-Medrol in treating patients with osteoarthritis (OA) of the hip. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Musculoskeletal Diseases
- What is being tested?
- Synvisc (hylan G-F 20)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 32 sitesUnited States
- Study dates
- Nov 2003to Apr 2006
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic osteoarthritis pain of hip
Who cannot join
- Patients with current or prior conditions or treatment that would impede measurement of efficacy and safety
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Maryland General Hospital
Baltimore, Maryland, 21201
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
David S. Tearse, MD (Private Practice)
Cedar Rapids, Iowa, 52403
Chattanooga Center for Sports
Chattanooga, Tennessee, 37404
Northwestern Orthopaedic Institute
Chicago, Illinois, 60611
Orthopedic Specialists of Tamp Bay, P.A.
Clearwater, Florida, 33756
Hughston Sports Medicine Foundation
Columbus, Georgia, 31909
Conway Medical Center
Conway, South Carolina, 29526
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Family Orthopedic Associates
Flint, Michigan, 48507
Orthopedic Center for Joint Replacement & Sports Medicine
Grants Pass, Oregon, 97527
John Higginbotham, MD Sports Medicine
Huntsville, Alabama, 35802
Lancaster Orthopedic Group
Lancaster, Pennsylvania, 17601
Kansas City Orthopedic Institute
Leawood, Kansas, 66211
Bluegrass Orthopaedics
Lexington, Kentucky, 40509
Arkansas Orthopaedic Specialists
Little Rock, Arkansas, 72205
Cedars-Sinai Orthopedic Center
Los Angeles, California, 90048
Gurdev Gill, MD (Private Practice)
Lubbock, Texas, 79410
Idaho Arthritis & Osteoporosis Center
Meridian, Idaho, 83642
Orthopedic Institute at Mercy Hospital
Miami, Florida, 33133
Illinois Bone and Joint Institute, Ltd.
Morton Grove, Illinois, 60053
UMDNJ-RWJ University Orthopedic Group
New Brunswick, New Jersey, 08901
Hospital for Special Surgery
New York, New York, 10021
Jackson Arthritis Center
Oakland, California, 94609
Health Research Institute
Oklahoma City, Oklahoma, 73109
Allegheny Orthopedic Associates
Pittsburgh, Pennsylvania, 15212
Orthopedic Medical Group
San Diego, California, 92123
Affiliated Orthopedic Specialists
Scottsdale, Arizona, 85260
Arthritis Northwest
Seattle, Washington, 98166-2967
Orthopedic Specialists of Louisiana
Shreveport, Louisiana, 71101
Washington University School of Medicine
St Louis, Missouri, 63110
Carilion Bone and Joint Center, Vinton Orthopedic Surgery
Vinton, Virginia, 24179
About this study
This is a clinical study to investigate the safety and efficacy of Synvisc and Depo-Medrol in treating patients with osteoarthritis (OA) of the hip.
- Conditions
- Osteoarthritis, Hip, Musculoskeletal Diseases
- Being tested
- Synvisc (hylan G-F 20)
- Keywords
- osteoarthritis of the hip, Musculoskeletal Diseases
- Medical subject headings
- Osteoarthritis, Hip, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc (hylan G-F 20)Device
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 posted18 Aug 2005 (estimated)
- Study startNov 2003
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies 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
- NCT00131326
- Sponsor's protocol ID
- SYNV-004-02
- Status last verified
- Jul 2017
- First submitted
- 17 Aug 2005
- Last updated
- 31 Jul 2017
- Results posted
- No
Publications
Spitzer AI, Bockow BI, Brander VA, Yates JW, MacCarter DK, Gudger GK, Haller S, Lake SL, Magilavy DB. Hylan G-F 20 improves hip osteoarthritis: a prospective, randomized study. Phys Sportsmed. 2010 Jun;38(2):35-47. doi: 10.3810/psm.2010.06.1781.
PubMed 20631462
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip
- ClinicalTrials.gov ID
- NCT00131326
- Acronym / sponsor ID
- SYNV-004-02
- Conditions
- Osteoarthritis, Hip, Musculoskeletal Diseases
- Keywords
- osteoarthritis of the hip, Musculoskeletal Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Apr 2006
- First posted
- 18 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 Synvisc and Depo-Medrol in treating patients with osteoarthritis (OA) of the hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic osteoarthritis pain of hip
Key exclusion criteria (1 listed)
- Patients with current or prior conditions or treatment that would impede measurement of efficacy and safety
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 |
|---|---|---|
| Synvisc (hylan G-F 20) | 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 31 Jul 2017.
- Background: PubMed 20631462Spitzer AI, Bockow BI, Brander VA, Yates JW, MacCarter DK, Gudger GK, Haller S, Lake SL, Magilavy DB. Hylan G-F 20 improves hip osteoarthritis: a prospective, randomized study. Phys Sportsmed. 2010 Jun;38(2):35-47. doi: 10.3810/psm.2010.06.1781.
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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
32 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 Synvisc (hylan G-F 20) in people with Osteoarthritis, Hip and Musculoskeletal Diseases, run by Genzyme, a Sanofi Company at 32 sites in United States.
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 1 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 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. 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?
On the ClinicalTrials.gov record for NCT00131326, which also lists 1 linked publication.
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 31 Jul 2017.