Safety and Efficacy Study of NV-101 in Dental Patients

September 12, 2005 updated by: Novalar Pharmaceuticals, Inc.

A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of NV-101 in Dental Patients

The purpose of this study was:

  • to determine if NV-101 accelerates recovery from numbness compared to placebo
  • to evaluate safety of NV-101

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a randomized, double-blind, placebo-controlled, multi-center study. One hundred twenty-two patients aged 10-58 requiring treatment with one of four routine dental procedures were enrolled. The investigators were licensed dentists in private practice. Each patient received one or more conventional injections of either articaine with epinephrine, lidocaine with epinephrine, prilocaine with epinephrine, or mepivacaine with levonordefrin. Local anesthetics were injected into no more than 2 sites. Injections of local anesthetic placed within 4mm of each other constituted the same site. The injection(s) of study drug were made at or near the completion of the dental procedure and were required to be not earlier than 20 minutes after, and not later than 70 minutes after, the most recent injection of local anesthetic. Patients received an injection of study drug (1.8 mL) in each site at which local anesthetic had been injected (i.e. no more than 2 sites).

Patients self-evaluated the return of normal sensation in the lip, tongue, nose, and chin by palpations at 5-minute intervals beginning 1 minute before the study drug injection and continuing for a minimum of 3 hours and until they achieved the return of normal sensation in lip, tongue, nose, and chin.

Safety was assessed by the use of a Holter monitor, vital signs, pain ratings, and physical examinations including oral cavity examinations.

Study Type

Interventional

Enrollment

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98403
        • Northwest Kinetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 10-65 years of age
  • Body weight between 35 to 110 kg
  • Healthy as determined by the Investigator based on medical history, physical examination, and 12 Lead ECG
  • Clinical laboratory tests within the reference ranges or within clinically acceptable limits according to the Investigator
  • Normal lip, nose, chin, and tongue sensations
  • Women of childbearing potential must have agreed to use barrier contraception for the duration of the study (Women of childbearing potential included all women except for those who are premenstrual, whose menstrual periods have not occured for greater than or equal to one year after menopause, who are surgically sterilized, or who have had a hysterectomy)
  • Can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol

Exclusion Criteria:

  • Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue disease or disorder
  • Clinically relevant surgical history
  • History of alcoholism and/or drug abuse within the past 5 years
  • Significant infection or known inflammatory process including viral infections
  • Required prophylactic antibiotics for SBE (infectious endocarditis)
  • Had acute gastrointestinal symptoms at screening and/or baseline
  • Allergies to any of the following: lidocaine/epinephrine, articaine/epinephrine, prilocaine/epinephrine, bisulfites or metasulfites, or phentolamine
  • Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline
  • Used pain relievers 24 hours prior to anesthetic administration
  • Required the use of nitrous oxide or sedatives to perform the scheduled, eligible dental procedure
  • Pregnancy, attempting to conceive,or lactating
  • Used decongestants or other drugs with vasoactive moieties within 24 hours prior to anesthetic administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novalar Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Royce Morrison, MD, Northwest Kinetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

June 1, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 14, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOVA 03-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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