OsteoarthritisPhase 3NCT00131300
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
A Phase 3 study testing Synvisc (hylan G-F 20) in people with Osteoarthritis and Musculoskeletal Diseases, run by Genzyme, a Sanofi Company at 6 sites in 2 countries.
Trial summary
This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Musculoskeletal Diseases
- What is being tested?
- Synvisc (hylan G-F 20)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 6 sitesin 2 countries
- Study dates
- Apr 2004to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic OA pain of shoulder (gleno-humeral)
Who cannot join
- Patients with current or prior conditions or treatment that would impede measurement of efficacy or safety
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France4 sites
Hopital Ambroise Pare
Boulogne-Billancourt, 92100
Clinique Saint Anne Lumiere
Lyon, 69003
Centre de Medecine et Traumatologie du Sport Clinique du Sport
Mérignac, 33700
CHRU Hopital Trousseau
Tours, 37044
Germany2 sites
August-Viktoria-Klinik
Bad Oeynhausen, 32545
Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin
Halle, 06097
About this study
This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.
- Conditions
- Osteoarthritis, Musculoskeletal Diseases
- Being tested
- Synvisc (hylan G-F 20)
- Keywords
- Osteoarthritis of the shoulder, Musculoskeletal
- Medical subject headings
- Osteoarthritis, 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 startApr 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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
- NCT00131300
- Sponsor's protocol ID
- SYNV-002-01
- Status last verified
- Mar 2015
- First submitted
- 17 Aug 2005
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
- ClinicalTrials.gov ID
- NCT00131300
- Acronym / sponsor ID
- SYNV-002-01
- Conditions
- Osteoarthritis, Musculoskeletal Diseases
- Keywords
- Osteoarthritis of the shoulder, Musculoskeletal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Feb 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 clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic OA pain of shoulder (gleno-humeral)
Key exclusion criteria (1 listed)
- Patients with current or prior conditions or treatment that would impede measurement of efficacy or 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 18 Mar 2015.
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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
6 sites in 2 countries: 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 and Musculoskeletal Diseases, run by Genzyme, a Sanofi Company at 6 sites in 2 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 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Germany. 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 18 Mar 2015.