Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245271
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2005-10-26
Brief Title:
Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament ACL Reconstruction
Sponsor:
Omeros Corporation
Organization:
Omeros Corporation
Study Overview
Official Title:
Double-Blind Multicenter Study Evaluating the Safety of OMS103HP and Vehicle in Subjects Undergoing Anterior Cruciate Ligament Reconstruction With an Open-Label Phase Containing a PK Analysis in a Subset of Subjects
Status:
COMPLETED
Status Verified Date:
2011-06
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:
OMS103HP is being developed for improvement in knee function following ACL reconstruction Secondary benefits being evaluated include reduced postoperative pain improvement in knee motion and earlier return to work
Detailed Description:
The anterior cruciate ligament ACL is an important stabilizer of the knee Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery Surgical trauma initiates an acute inflammatory response including swelling and pain that leads to restricted joint motion and loss of function Because of the dynamic nature complexity and redundancy of the chemical mediators of inflammation and pain and their pathways no currently available single drug has sufficiently broad spectrum of activity to effectively inhibit the inflammatory process OMS103 provides a multicomponent approach to controlling the inflammation induced by arthroscopic surgery It delivers three active ingredients each with distinct pharmacological activities directly to the site of surgical procedures to preemptively block the inflammatory cascade induced by surgical trauma
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