Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT00154167
Status:
COMPLETED
Last Update Posted:
2005-09-14
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of NV-101 in Dental Patients
Sponsor:
Novalar Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of NV-101 in Dental Patients
Status:
COMPLETED
Status Verified Date:
2005-09
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:
The purpose of this study was:
* to determine if NV-101 accelerates recovery from numbness compared to placebo
* to evaluate safety of NV-101
* to determine if NV-101 accelerates recovery from numbness compared to placebo
* to evaluate safety of NV-101
Detailed Description:
This was a randomized, double-blind, placebo-controlled, multi-center study. One hundred twenty-two patients aged 10-58 requiring treatment with one of four routine dental procedures were enrolled. The investigators were licensed dentists in private practice. Each patient received one or more conventional injections of either articaine with epinephrine, lidocaine with epinephrine, prilocaine with epinephrine, or mepivacaine with levonordefrin. Local anesthetics were injected into no more than 2 sites. Injections of local anesthetic placed within 4mm of each other constituted the same site. The injection(s) of study drug were made at or near the completion of the dental procedure and were required to be not earlier than 20 minutes after, and not later than 70 minutes after, the most recent injection of local anesthetic. Patients received an injection of study drug (1.8 mL) in each site at which local anesthetic had been injected (i.e. no more than 2 sites).
Patients self-evaluated the return of normal sensation in the lip, tongue, nose, and chin by palpations at 5-minute intervals beginning 1 minute before the study drug injection and continuing for a minimum of 3 hours and until they achieved the return of normal sensation in lip, tongue, nose, and chin.
Safety was assessed by the use of a Holter monitor, vital signs, pain ratings, and physical examinations including oral cavity examinations.
Patients self-evaluated the return of normal sensation in the lip, tongue, nose, and chin by palpations at 5-minute intervals beginning 1 minute before the study drug injection and continuing for a minimum of 3 hours and until they achieved the return of normal sensation in lip, tongue, nose, and chin.
Safety was assessed by the use of a Holter monitor, vital signs, pain ratings, and physical examinations including oral cavity examinations.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: