OsteoarthritisPhase 1NCT00949494
Effects of Synvisc on Cartilage in Knee Osteoarthritis (OA)
A Phase 1 study testing Synvisc in people with Osteoarthritis, run by Endeavor Health at 2 sites in United States.
Trial summary
Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative used to treat knee osteoarthritis (OA). Animal studies have shown that Synvisc can have favorable effects on cartilage when injected into joints. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Synvisc
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Feb 2009
- Phase
- Phase 1
- 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
- Males and females 40 to 80 years of age who meet the ACR Criteria for osteoarthritis of the knee.
- Radiographic evidence of OA, Kellgren and Lawrence grade I to III on prior X-rays (taken within 6 months of the screening visit) or at screening. Only the tibio-femoral joint will be evaluated (patello-femoral disease will not be considered).
- Mild to moderate levels of knee pain as determined by a VAS pain score of 3-6/10 that has been stable for at least 1 month prior to screening visit.
- Stable management regimen for knee OA pain for at least 1 month prior to screening visit. Subjects can be managed by physical measures alone, simple analgesics, NSAIDs, nutriceuticals or other agents with no significant change in treatment regimen during the 1 month prior to screening visit.
- Ability to comply with the requirements of the study
- Able to maintain stable exercise/activity program during course of the study
- 6. Signed and dated consent form 7. Women of child-bearing potential should agree to the use of an appropriate method of contraception and have a confirmed negative pregnancy test at screening.
Who cannot join
- Radiographic evidence of Kellgren and Lawrence grade IV OA
- Knee pain <3 or >6 out of 10 on VAS pain scale.
- Change in management regimen for knee OA during the preceding month.
- Subjects with any metal implant such as cardiac pacemakers, spinal cord stimulators or bionic ear devices.
- Subjects who are unable to receive gadolinium contrast agent injection because of contraindications.
- Unable to undergo an MRI exam because of contraindication, e.g. claustrophobia.
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- Inflammatory arthritis, e.g. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus.
- History of other diseases that may involve the study joint including inflammatory joint disease, crystalline disease, endocrinopathies, metabolic disease, knee infection of the chosen knee, neuropathic disorders, avascular necrosis, Paget's disease or tumors
- Recent trauma to study joint.
- Known loose bodies in the study joint.
- Patients taking oral steroids.
- Patients with active malignancy.
- Patients who are either high-performance athletes or, in the opinion of the investigator, are highly sedentary and not likely to ambulate at least 20-30 minutes/day.
- In the opinion of the investigator, the subject has an unstable medical condition.
- Participating in another study or has participated in a study evaluating investigational drugs, devices or biologics within three months of enrollment in this study.
- Study subject has ever previously received hyaluronan therapy.
- Arthroscopic or open surgery to the study joint within the previous twelve months.
- Anticipated need for knee surgery to the study joint.
- History of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the study knee.
- Intra-articular injection of corticosteroid to study joint within the past six months.
- Morbid obesity defined as BMI of greater than 40.
- Study subject has known sensitivity to any component of Hylan G-F 20 including bird feathers, eggs or poultry.
- Subject has an active systemic infection.
- Subject on coumadin or other anticoagulant.
- Musculoskeletal pain that may preclude the subject from remaining motionless for the MRI exam.
- Women who are pregnant or lactating.
- Subjects with "clinically significant" malalignment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Northshore University Hospital
Evanston, Illinois, 60201
About this study
Official title: Pilot Trial of Effects of Intra-articular Synvisc Therapy on Cartilage Determined by dGEMRIC in Patients With OA of the Knee
Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative used to treat knee osteoarthritis (OA). Animal studies have shown that Synvisc can have favorable effects on cartilage when injected into joints. This study attempts to evaluate the effects of Synvisc when injected into knees of patients with knee OA by means of a specialized MRI technology (dGEMRIC).
Read the detailed description
Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative which is administered by injection into osteoarthritic joints for the treatment of osteoarthritis. Preclinical investigations have demonstrated that Hylan G-F 20 can favorably affect chondrocyte metabolism and recent clinical studies [Ann Rheum Dis. 2004 May;63(5):478-82; Osteoarthritis Cartilage. 2005 Mar;13(3):216-24] provide support for a disease-modifying effect of Hylan G-F 20 therapy. This study will utilize dGEMRIC imaging of patients with knee OA to assess the effects of Hylan G-F 20 therapy on cartilage in vivo over time. Delayed Gadolinium Enhanced MRI of the Cartilage (dGEMRIC) permits a quantitative assessment of GAG distribution within intact cartilage in vivo. Since dGEMRIC is noninvasive, the technique may be useful to non-invasively monitor the influence of various treatments on hyaline cartilage.
- Conditions
- Osteoarthritis
- Being tested
- Synvisc
- Keywords
- knee osteoarthritis, synvisc, hyaluronan, dGEMRIC,cartilage
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynviscDevice
Also called hyaluronan
intra-articular, 3 weekly injections
| Study group | Role | What they receive |
|---|---|---|
| Synvisc | Active comparator | Not described Receives: Device: Synvisc |
| Placebo | Placebo comparator | Not described Receives: Device: Synvisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in dGEMRIC Index (T1(Gd)) in femoral and tibial compartments
Measured: 3 and 6 months
Secondary outcomes (1)
Subjects' global assessment of disease using a 10 point Likert scale
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionFeb 2009
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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Northwestern University
- Responsible party
- Principal investigator, Pottumarthi Prasad, Endeavor Health
- Investigators
- Pottumarthi V Prasad, PhD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949494
- Sponsor's protocol ID
- EH 06-159
- Status last verified
- Sep 2019
- First submitted
- 29 Jul 2009
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Effects of Intra-articular Synvisc Therapy on Cartilage Determined by dGEMRIC in Patients With OA of the Knee
- ClinicalTrials.gov ID
- NCT00949494
- Acronym / sponsor ID
- EH 06-159
- Conditions
- Osteoarthritis
- Keywords
- knee osteoarthritis, synvisc, hyaluronan, dGEMRIC,cartilage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Northwestern University
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 30 Jul 2009 (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.
Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative used to treat knee osteoarthritis (OA). Animal studies have shown that Synvisc can have favorable effects on cartilage when injected into joints. This study attempts to evaluate the effects of Synvisc when injected into knees of patients with knee OA by means of a specialized MRI technology (dGEMRIC).
Detailed description
Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative which is administered by injection into osteoarthritic joints for the treatment of osteoarthritis. Preclinical investigations have demonstrated that Hylan G-F 20 can favorably affect chondrocyte metabolism and recent clinical studies [Ann Rheum Dis. 2004 May;63(5):478-82; Osteoarthritis Cartilage. 2005 Mar;13(3):216-24] provide support for a disease-modifying effect of Hylan G-F 20 therapy. This study will utilize dGEMRIC imaging of patients with knee OA to assess the effects of Hylan G-F 20 therapy on cartilage in vivo over time. Delayed Gadolinium Enhanced MRI of the Cartilage (dGEMRIC) permits a quantitative assessment of GAG distribution within intact cartilage in vivo. Since dGEMRIC is noninvasive, the technique may be useful to non-invasively monitor the influence of various treatments on hyaline cartilage.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synvisc | Active comparator | Device: Synvisc |
| Placebo | Placebo comparator | Device: Synvisc |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females 40 to 80 years of age who meet the ACR Criteria for osteoarthritis of the knee.
- Radiographic evidence of OA, Kellgren and Lawrence grade I to III on prior X-rays (taken within 6 months of the screening visit) or at screening. Only the tibio-femoral joint will be evaluated (patello-femoral disease will not be considered).
- Mild to moderate levels of knee pain as determined by a VAS pain score of 3-6/10 that has been stable for at least 1 month prior to screening visit.
- Stable management regimen for knee OA pain for at least 1 month prior to screening visit. Subjects can be managed by physical measures alone, simple analgesics, NSAIDs, nutriceuticals or other agents with no significant change in treatment regimen during the 1 month prior to screening visit.
- Ability to comply with the requirements of the study
Key exclusion criteria (27 listed)
- Radiographic evidence of Kellgren and Lawrence grade IV OA
- Knee pain <3 or >6 out of 10 on VAS pain scale.
- Change in management regimen for knee OA during the preceding month.
- Subjects with any metal implant such as cardiac pacemakers, spinal cord stimulators or bionic ear devices.
- Subjects who are unable to receive gadolinium contrast agent injection because of contraindications.
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 |
|---|---|---|
| SynviscAlso: hyaluronanintra-articular, 3 weekly injections | Device | Placebo, Synvisc |
Primary outcome
Percent change in dGEMRIC Index (T1(Gd)) in femoral and tibial compartments
Time frame: 3 and 6 months
1 secondary outcome
Subjects' global assessment of disease using a 10 point Likert scale
Time frame: 3 and 6 months
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 10 Sep 2019.
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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.
Pottumarthi V Prasad, PhD principal investigator
Endeavor Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Synvisc in people with Osteoarthritis, run by Endeavor Health at 2 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 7 inclusion and 27 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 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percent change in dGEMRIC Index (T1(Gd)) in femoral and tibial compartments (time frame: 3 and 6 months). 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 10 Sep 2019.