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Synvisc

Phase 3

Osteoarthritis | Unknown | Musculoskeletal |Sanofi|Last Updated: Sep 10, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Synvisc · 4 trials · 3 indications

Phase 3 3Phase 1 1
NCT00131300A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder OsteoarthritisOsteoarthritis
COMPLETED- Analytics
NCT00131326A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the HipOsteoarthritis, Hip
COMPLETED- Analytics
NCT00131768A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle OsteoarthritisOsteoarthritis
COMPLETED- Analytics
PHASE3COMPLETED
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
OsteoarthritisUnlock trial analytics
PHASE3COMPLETED
A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip
Osteoarthritis, HipUnlock trial analytics
PHASE3COMPLETED
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle Osteoarthritis
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Pain relief
Percent change in dGEMRIC Index (T1(Gd)) in femoral and tibial compartments
3 and 6 months

Secondary Endpoints

Subjects' global assessment of disease using a 10 point Likert scale
3 and 6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SynviscACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Synvisc (hylan G-F 20)DEVICE -
SynviscDEVICEintra-articular, 3 weekly injections
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Patients with symptomatic OA pain of shoulder (gleno-humeral) Exclusion Criteria: * Patients with current or prior conditions or treatment that would impede measurement of efficacy or safety

Countries:FranceGermanyUnited StatesItalyNetherlands
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Frequently asked questions about Synvisc

What is Synvisc used for?

Synvisc is used for osteoarthritis, including osteoarthritis of the hip and symptomatic shoulder and ankle osteoarthritis. It is a viscosupplementation product developed by Sanofi for the treatment of osteoarthritis in various joints.

What does Synvisc target?

Synvisc is a viscosupplement that targets the joint space in osteoarthritis. It is designed to supplement the synovial fluid in joints affected by osteoarthritis, providing lubrication and cushioning to reduce pain and improve joint function.

Who makes Synvisc?

Synvisc is developed by Sanofi, a multinational pharmaceutical company. Sanofi is publicly traded under the ticker symbol SNY on the NASDAQ stock exchange.

What phase is Synvisc in?

Synvisc is in Phase 3 clinical development for osteoarthritis. It has completed three Phase 3 trials in shoulder, hip, and ankle osteoarthritis, and it is not FDA approved based on the available data.

What clinical trials is Synvisc in?

Synvisc has completed three Phase 3 trials: NCT00131300 for shoulder osteoarthritis, NCT00131326 for hip osteoarthritis, and NCT00131768 for ankle osteoarthritis. All trials are completed, with no active trials currently.

Is Synvisc the same as hylan G-F 20?

Synvisc is a brand name for hylan G-F 20, a derivative of hyaluronan. It is used for osteoarthritis treatment and is developed by Sanofi.