At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 381 enrolled
Drug / intervention
Sinovial® (syringe containing sodium hyaluronate solution) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy Evaluation of Intra-articular Hyaluronic Acid (Sinovial®) vs Synvisc® in the Treatment of Symptomatic Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study
In Brief
A Phase 4 clinical trial evaluating Sinovial® (syringe containing sodium hyaluronate solution) and Synvisc® ( syringe containing Hylan G-F 20 solution) for Osteoarthritis, Knee. Completed, enrolled 381 participants across 20 sites in 6 countries.
Detailed Summary
The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesCzechia, France, Germany, Italy, Slovakia, Switzerland
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedNov 2007
Primary CompletionJul 2009
Study CompletionMay 2010
TodayJul 2026
First PostedNov 12, 2007
Enrollment StartNov 1, 2007
Primary CompletionJul 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.6 years ago
Interventions
Sinovial® (syringe containing sodium hyaluronate solution)device
2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.
Synvisc® ( syringe containing Hylan G-F 20 solution)device
2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.