Clinical Trial: The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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).


Detailed Summary:
Sponsor: Daiichi Sankyo Inc.

Current Primary Outcome: Change in overall pain, 3 months after a single intra-articular injection. The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip. [ Time Frame: 3 months ]

Original Primary Outcome:

  • Change in overall pain, 3 months after a single intra-articular injection.
  • The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip irrespective of the circumstances of the previous 48 hours.


Current Secondary Outcome:

  • Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion) [ Time Frame: 3 months ]
  • WOMAC index (the 3 subscales) [ Time Frame: 3 months ]
  • Consumption of analgesics and NSAIDs [ Time Frame: 3 months ]
  • Evaluation of tolerability (AE reporting) [ Time Frame: 3 months ]


Original Secondary Outcome:

  • Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)
  • WOMAC index (the 3 subscales)
  • Consumption of analgesics and NSAIDs
  • Evaluation of tolerability (AE reporting)


Information By: Daiichi Sankyo Inc.

Dates:
Date Received: May 23, 2006
Date Started: January 2005
Date Completion:
Last Updated: January 7, 2008
Last Verified: January 2008