Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309361
Status:
COMPLETED
Last Update Posted:
2006-11-17
First Post:
2006-03-30
Brief Title:
Study of NV-101 for Efficacy Pharmacodynamics and Safety in Dental Patients Undergoing Mandibular Procedures
Sponsor:
Novalar Pharmaceuticals Inc
Organization:
Novalar Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Blinded Controlled Study of NV-101 for Efficacy Pharmacodynamics and Safety in Dental Patients Undergoing Mandibular Procedures
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 3 study is designed as a multicenter randomized blinded controlled study to evaluate the efficacy pharmacodynamics and safety of NV-101 administered as a submucosal injection following completion of a restorative or periodontal maintenance procedure requiring local anesthesia with an agent containing a vasoconstrictor Local vasodilation that results in more rapid clearance of the anesthetic is the proposed mechanism of action
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