At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 394 enrolled
Drug / intervention
Synvisc-Onedrug
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.
A Multicenter, Prospective, Open-Label Study of the Safety and Efficacy of 6 mL Synvisc-One ® (Hylan G F 20) in Indian Patients With Symptomatic Osteoarthritis of the Knee(s) After Initial and Repeat Treatment
In Brief
A Phase 4 clinical trial evaluating Synvisc-One for Osteoarthritis. Completed, enrolled 394 participants.
Detailed Summary
Primary Objective: To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s). Secondary Objective: To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
Primary CompletionSep 2011
First PostedMar 2015
TodayJul 2026
First PostedMar 17, 2015
Enrollment StartFeb 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.3 years ago
Interventions
Synvisc-Onedrug
intraarticular injection