NCT01265459

Different Volumes of Durolane in Knee OA

Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.

Detailed description

To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml	Durolane is an intraarticular hyaluronic acid preparation

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-09-01
• Completion: 2011-11-01
• First posted: 2010-12-23
• Last updated: 2022-09-22
• Results posted: 2014-01-20

Locations

3 sites across 1 country: Sweden