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A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle Osteoarthritis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131768
Enrollment
Unknown
Registered
2005-08-19
Start date
2003-11-30
Completion date
2006-02-28
Last updated
2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

osteoarthritis of the ankle, musculoskeletal

Brief summary

This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic ankle osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the initial 3 months follow up period.

Interventions

Sponsors

Genzyme, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with symptomatic OA pain of ankle (talo-crural)

Exclusion criteria

* Patients with current or prior conditions or treatments that would impede measurements of efficacy or safety

Design outcomes

Primary

MeasureTime frame
Pain relief

Countries

Germany, Italy, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026