drugset / Trial / NCT00309361

Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Mandibular Procedures

NCT00309361

Phase 3 Completed 240 enrolled Novalar Pharmaceuticals, Inc.
RandomizedSingle-groupSingle-blindTreatment

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.

Timeline

Start
2006-02
Primary completion
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Phentolamine Small molecule Other

Indications

No indication recorded.