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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Synvisc-One	intraarticular injection

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2015-03-17
• Last updated: 2017-08-07
• Results posted: 2015-05-21