Who is sponsoring NCT00309335?

NCT00309335 is sponsored by Novalar Pharmaceuticals, Inc..

What condition does NCT00309335 study?

NCT00309335 studies Anesthesia, Dental.

What drugs are being tested in NCT00309335?

Interventions: Phentolamine Mesylate (NV-101).

What is the status of NCT00309335?

NCT00309335 is currently COMPLETED.

Last reviewed 2006-11-16 · How we verify

A Phase 3, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Efficacy, Pharmacodynamics and Safety in Dental Patients Undergoing Maxillary Procedures

NCT00309335 Phase 3 COMPLETED

This Phase 3 clinical 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 vasodilatation that results in more rapid clearance of the anesthetic is the proposed mechanism of action.

Details

Lead sponsor	Novalar Pharmaceuticals, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	240
Start date	2006-02
Completion	2006-07

Conditions

Anesthesia, Dental

Interventions

Phentolamine Mesylate (NV-101)

Primary outcomes

to determine if NV-101 accelerates time to normal sensation of the upper lip compared to control, as measured by standardized palpation procedure

Countries

United States