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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Novalar Pharmaceuticals, Inc.

Current Primary Outcome: to determine if NV-101 accelerates time to normal sensation of the lower lip compared to control, as measured by standardized palpation procedure

Original Primary Outcome: to determine if NV-101 accelerates time to normal sensation of the lower lip compared to control as measured by standardized palpation procedure

Current Secondary Outcome:

  • to determine if NV-101 accelerates the time to STAR-7 score of zero, as measured by soft tissue anesthesia questionnaire
  • to determine if NV-101 accelerates the time to normal function, as measured by a functional assessment battery
  • to determine if NV-101 accelerates the time to normal sensation of the tongue, as measured by standardized palpation procedure
  • to characterize the pharmacodynamic profile of NV-101, as measured by onset and offset of treatment effect
  • to evaluate the safety and tolerability of NV-101


Original Secondary Outcome:

  • to determine if NV-101 accelerates the time to STAR-7 score of zero as measured by soft tissue anesthesia questionnaire
  • accelerates, the time to normal function as measured by a functional assessment battery
  • accelerates, the time to normal sensation of the tongue as measured by standardized palpation procedure
  • to characterize the pharmacodynamic profile of NV-101 as measured by onset and offset of treatment effect
  • to evaluate the safety and tolerability of NV-101


Information By: Novalar Pharmaceuticals, Inc.

Dates:
Date Received: March 30, 2006
Date Started: February 2006
Date Completion: July 2006
Last Updated: November 16, 2006
Last Verified: November 2006