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

NCT00309335 | Completed Phase 3

• 1 other identifier: NOVA 04-200
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Dental

Keywords

Soft Tissue Anesthesia (Numbness)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

Phentolamine Mesylate (NV-101) DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 maxilla 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 upper 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
• Normal upper lip sensations at baseline prior to administration of local anesthetic
• Upper lip on the side of the procedure is numb (no feeling) at the completion of the dental procedure
• Soft tissue anesthesia recovery score of zero prior to anesthetic
• Functional Assessment Battery by subject and observer rating is normal prior to anesthetic
• Negative urine pregnancy test at screening in all females of childbearing potential past menarche (includes all females except for those whose menstrual periods have not occured for greater than or equal to 1 year after menopause, who are surgically sterilized, or who had a hysterectomy)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novalar Pharmaceuticals, Inc.: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Hypesthesia

Interventions

Phentolamine

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Athena Papas, DMD

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2006
• First Posted: March 31, 2006
• Study Start: February 1, 2006
• Study Completion: July 1, 2006
• Last Updated: November 17, 2006

Record last verified: 2006-11

Locations

US (1)