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

Novalar Pharmaceuticals, Inc.1 site in 1 country240 target enrollmentFebruary 2006

ConditionsAnesthesia, Dental

DrugsPhentolamine Mesylate (NV-101)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Anesthesia, Dental
Sponsor: Novalar Pharmaceuticals, Inc.
Enrollment: 240
Locations: 1
Primary Endpoint: to determine if NV-101 accelerates time to normal sensation of the lower lip compared to control, as measured by standardized palpation procedure
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

July 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novalar Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•Male or female greater than or equal to 12 years
•Sufficiently healthy, as determined by the Investigator, to receive routine dental care
•Requires a restorative procedure in the mandible such as cavity preparation, restoration/filling, or crown or a periodontal maintenance procedure, such as teeth cleaning (non-surgical scaling and/or root planing) on the same side of the lower mouth
•Requires one or two cartridges of local anesthesia administered by one of the following intraoral injection techniques:
•inferior alveolar nerve block;
•Gow-Gates nerve block;
•Vazirani-Akinosi block;
•mental-incisive block; or
•supraperiosteal injection.
•Dental procedure is completed within 60 minutes of the first administration of local anesthetic

Exclusion Criteria

•History or presence of any condition that contraindicates routine dental care
•Requires more than two cartridges of local anesthetic (excluding supplemental injections) or use of nitrous oxide or sedatives to perform the scheduled dental procedure
•Scheduled dental procedure takes greater than 60 minutes to complete
•Unable to tolerate 1 liter of water over 5 hours
•Concurrent conditions: any incapacitating medical condition (e.g. unstable angina, uncontrolled cardiac arrhythmias, uncontrolled hypertension, uncontrolled hyperthyroidism); significant infection or inflammatory process of the oral cavity.
•Concomitant medications: use of an opioid or opioid-like analgesic (e.g. codeine, tramadol, pentazocine) within 24 hours prior to administration of anesthetic
•Allergy or intolerance to lidocaine, articaine, prilocaine, mepivacaine, epinephrine, levonordefrin, sulfites, phentolamine, or topical benzocaine
•Has used an investigational drug and/or participated in any clinical study within 30 days of study drug administration
•Has participated in this study or any previous study of phentolamine mesylate for reversal of local soft tissue anesthesia (STA)
•Any condition which, in the opinion of the Investigator, increases the risk to the subject of participating in this study or decreases the likelihood of compliance with the protocol

Outcomes

Primary Outcomes

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

Secondary Outcomes

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