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Synvisc

Phase 3

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

Synvisc development status

Highest phase Phase 3
Registered trials 3 across 3 sponsors since Sep 2005

Synvisc target and mechanism

ModalityUnknown

Also known as hyaluronan

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment30

FDA Designations

No designations recorded

Synvisc clinical trials

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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Competitive Landscape -Osteoarthritis 143 trials

Frequently asked questions about Synvisc

What is Synvisc used for?

Synvisc is used for osteoarthritis, including osteoarthritis of the hip, shoulder, and ankle. It is a viscosupplementation product being studied in Phase 3 clinical trials for these indications. The drug is developed by Sanofi and is intended to treat pain and improve joint function in patients with osteoarthritis.

What does Synvisc target?

Synvisc is a viscosupplementation product that targets osteoarthritis by supplementing the synovial fluid in joints. It is designed to restore the viscoelastic properties of the joint fluid, which can become degraded in osteoarthritis. This helps to lubricate the joint and act as a shock absorber, potentially reducing pain and improving mobility.

Who makes Synvisc?

Synvisc is developed by Sanofi, a multinational pharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the safety and efficacy of Synvisc in treating osteoarthritis in various joints, including the hip, shoulder, and ankle.

What phase is Synvisc in?

Synvisc is in Phase 3 clinical development for osteoarthritis. It has completed three Phase 3 trials, which studied its safety and efficacy in patients with symptomatic shoulder osteoarthritis, osteoarthritis of the hip, and symptomatic ankle osteoarthritis. These trials were randomized, double-blind, and placebo-controlled, and they have been completed.

What clinical trials is Synvisc in?

Synvisc has been studied in three completed Phase 3 clinical trials: NCT00131300 for shoulder osteoarthritis, NCT00131326 for hip osteoarthritis, and NCT00131768 for ankle osteoarthritis. Additionally, a Phase 1 trial (NCT00949494) examined its effects on cartilage in knee osteoarthritis. All trials are completed, with no active trials currently ongoing.

Is Synvisc the same as any other drug?

Synvisc is not known to be the same as any other drug, as no alternative names have been reported. It is a distinct viscosupplementation product developed by Sanofi for the treatment of osteoarthritis. Its unique formulation is being evaluated in clinical trials for its safety and efficacy in various joints.