NCT01209364

Durolane Versus Methylprednisolone in Knee Osteoarthritis

Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Durolane is a device, methylprednisolone in a drug	single intraarticular injection

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-01-01
• Completion: 2008-11-01
• First posted: 2010-09-27
• Last updated: 2022-08-25

Locations

23 sites across 3 countries: Canada, Sweden, United Kingdom