drugset
drugset / Trial / NCT02389452

Study of Safety and Efficacy of 6 mL Synvisc-One (Hylan G-F 20) in Indian Patients With Symptomatic Osteoarthritis of Knee(s) After Initial and Repeat Treatment

NCT02389452 ↗

Phase 4 Completed 394 enrolled Genzyme, a Sanofi Company
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-02
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Hylan G-F 20 Other / unclassified 6 ml Other
Subject Hylan G-F 20 Other / unclassified 48 mg Other

Indications

osteoarthritis