search
Back to results

Safety and Efficacy Study of NV-101 in Dental Patients

Primary Purpose

Soft Tissue Anesthesia (Numbness)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NV-101 (phentolamine mesylate solution)
Sponsored by
Novalar Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Anesthesia (Numbness)

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwest Kinetics

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
September 12, 2005
Sponsor
Novalar Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00154167
Brief Title
Safety and Efficacy Study of NV-101 in Dental Patients
Official Title
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of NV-101 in Dental Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novalar Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study was: to determine if NV-101 accelerates recovery from numbness compared to placebo to evaluate safety of NV-101
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Anesthesia (Numbness)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
122 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NV-101 (phentolamine mesylate solution)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Royce Morrison, MD
Organizational Affiliation
Northwest Kinetics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Kinetics
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98403
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of NV-101 in Dental Patients

We'll reach out to this number within 24 hrs