drugset / Trial / NCT00330135

The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

NCT00330135

Phase 3 Terminated 85 enrolled Daiichi Sankyo
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2005-01
Primary completion
2007-03
Completion
2007-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Hyaluronate Other / unclassified 2.5 ml

Indications