NCT00669032

Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee

Random, Phase IV, Multicentre, Double Blind, Placebo Controlled, Parallel Study to Assess Long-term Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid (ADANT®) in Patients With Knee OA of the Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Tedec-Meiji Farma, S.A. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.

Detailed description

To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DEVICE	Hyaluronic acid	3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year
OTHER	Placebo	3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Timeline

• Start date: 2003-10-01
• Primary completion: 2009-07-01
• Completion: 2009-12-01
• First posted: 2008-04-29
• Last updated: 2023-08-28
• Results posted: 2016-02-15