Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330135
Status:
TERMINATED
Last Update Posted:
2008-01-09
First Post:
2006-05-23
Brief Title:
The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
Multicentre Randomized Placebo-Controlled Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis
Status:
TERMINATED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None