NCT00330135

The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip. Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months. At the third month, if the score for overall pain is still \> 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).

Conditions

• Symptomatic Hip Osteoarthritis

Interventions

Type	Name	Description
DRUG	Sodium hyaluronate	Sodium hyaluronate 2.5 ml - 1 injection
DRUG	placebo injection	placebo injection - 1 injection

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2006-05-25
• Last updated: 2008-01-09

Locations

1 site across 1 country: France