Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novocol Pharmaceutical of Canada, Inc.
Sponsor:
Information provided by (Responsible Party):
Novocol Pharmaceutical of Canada, Inc.
ClinicalTrials.gov Identifier:
NCT01474382
First received: November 11, 2011
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.


Condition Intervention Phase
Dental Anesthesia
Anesthesia, Local
Anesthesia, Reversal
Drug: OraVerse
Other: Sham injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4, Multicenter, Randomized, Double-Blinded, Controlled Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures

Resource links provided by NLM:


Further study details as provided by Novocol Pharmaceutical of Canada, Inc.:

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: Up to 3 days ] [ Designated as safety issue: Yes ]
  • Clinically significant changes in vital signs [ Time Frame: Up to 3 days ] [ Designated as safety issue: Yes ]
    Blood pressure and pulse

  • Clinically significant changes in oral cavity assessments [ Time Frame: Up to 3 days ] [ Designated as safety issue: Yes ]
  • Nerve injury [ Time Frame: Up to 3 days ] [ Designated as safety issue: Yes ]
  • Analgesics required for intraoral pain [ Time Frame: Up to 3 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence, severity and duration of intraoral pain as measured by W-B PRS [ Time Frame: Up to 3 days ] [ Designated as safety issue: Yes ]
    Wong-Baker Pain Rating Scale used to assess subject pain

  • Time to normal function [ Time Frame: Up to 3 days ] [ Designated as safety issue: No ]
    Measured by pediatric Functional Assessment Battery (pFAB) to determine when speaking, eating, drinking, drooling return to baseline

  • Time to normal lip sensation [ Time Frame: Up to 3 days ] [ Designated as safety issue: No ]
    Measures time to normal lip and tongue sensation using standardized lip/tongue palpation procedure

  • Time to normal tongue sensation [ Time Frame: Up to 3 days ] [ Designated as safety issue: No ]
    Measures time to normal tongue sensation using standardized lip/tongue palpation procedure


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OraVerse
OraVerse in doses of either 1/4, 1/2 or 1 cartridge (1.8mL)
Drug: OraVerse
1.8mL dental cartridge delivered in doses of either 1/4, 1/2 or 1 cartridge depending on subject weight
Sham Comparator: Sham injection
Dentist simulates injection with dental syringe
Other: Sham injection
No drug administered, simulation of injection used in same manner as drug

Detailed Description:

This Phase 4 clinical study is designed as a multicenter, randomized, double-blinded, controlled study to evaluate the safety and efficacy of OraVerse in approximately 150 children 2 to 5 years of age. OraVerse or sham injection is administered at the completion of a dental procedure requiring local anesthesia with lidocaine 2% with 1:100,000 epinephrine. The dental procedure(s) comprising restoration/fillings shall be performed in a single quadrant of the mouth.

The primary endpoint is safety and tolerability of OraVerse as measured by adverse events, vital signs, oral cavity assessments, nerve injury, and analgesics for intraoral pain. Secondary objectives in subjects 4 and 5 years of age include the safety and tolerability of OraVerse as measured by pain assessments using W-B PRS and evaluation of efficacy assessed by a pediatric Functional Assessment Battery (pFAB) and standardized lip and tongue palpation procedure.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 2 to 5 years of age
  • Sufficiently healthy as determined by the Investigator to receive routine dental care
  • Requires a restorative procedure (restoration/filling) in a single quadrant of the mouth
  • Requires local anesthesia with lidocaine 2% with 1:100,000 epinephrine administered by submucosal injection
  • For subjects undergoing mandibular procedures, require an inferior alveolar nerve block for the restorative procedure
  • Dental procedure(s) completed within 60 minutes of injection of local anesthetic
  • For subjects 4 and 5 years of age, can be trained in standardized lip/tongue palpation procedure and pFAB
  • Subjects who are trainable in pFAB and standardized lip/tongue palpation procedure have either:

    • normal pFAB at baseline prior to administration of local anesthetic and
    • at least one abnormal function (smiling, speaking, drinking or drooling) at the completion of the dental procedure OR
    • normal lip sensation at baseline prior to administration of local anesthetic and
    • numbness of the relevant lip quadrant at completion of the dental procedure
  • Subjects give written or verbal assent, as capable and appropriate, and parent(s) or legal guardian(s) give written informed consent

Exclusion Criteria:

  • Weight less than 10 kg
  • Weight less than 15 kg if 4 or 5 years of age
  • History or presence of any condition that contraindicates routine dental care or use of local anesthetic
  • Requires more than ¼ cartridge of local anesthetic if weight is ≥ 10 kg and < 15 kg, more than ½ cartridge of local anesthetic if weight is ≥ 15 kg and < 30 kg, and more than 1 cartridge of local anesthetic if weight is ≥ 30 kg, excluding supplemental injections
  • Allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, nitrous oxide or topical benzocaine
  • Has used any 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 use of commercial OraVerse™ within 30 days of study drug administration
  • Use of opioid or opioid-like analgesics within 24 hours prior to administration of local anesthetic
  • Requires the use of local anesthetic other than lidocaine 2% with 1:100,000 epinephrine to perform the scheduled dental procedure
  • Requires the use of general anesthesia or sedatives except for nitrous oxide to perform the scheduled dental procedure
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474382

Locations
United States, California
University of California, San Francisco Completed
San Francisco, California, United States, 94143
United States, Indiana
Indiana University School of Dentistry Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Judith Chin, DDS,MS    317-274-5420    jchin@iupui.edu   
Principal Investigator: Judith Chin, DDS,MS         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Paul Casamassimo, MS,DDS    614-722-5651    casamassimo.1@osu.edu   
Principal Investigator: Paul Casamassimo, MS,DDS         
United States, Pennsylvania
University of Pennsylvania School of Dental Completed
Philadelphia, Pennsylvania, United States, 19104-6030
University of Pittsburgh School of Dental Medicine Terminated
Pittsburgh, Pennsylvania, United States, 15261
United States, Utah
Jean Brown Research Completed
Salt Lake City, Utah, United States, 84124
United States, Washington
Center for Pediatric Dentistry Completed
Seattle`, Washington, United States, 98115
Sponsors and Collaborators
Novocol Pharmaceutical of Canada, Inc.
Investigators
Principal Investigator: Paul Moore, DMD,PhD,MPH University of Pittsburgh School of Dental Medicine
Principal Investigator: Elliot Hersh, DMD,MS,PhD University of Pennsylvania
Principal Investigator: Joel Berg, DDS,MS Seattle Children's Hospital
Principal Investigator: Judith Chin, DDS,MS Indiana University School of Dentistry
Principal Investigator: Brent Lin, DMD University of California, San Francisco
Principal Investigator: Paul Casamassimo, MS,DDS Nationwide Children's Hospital
Principal Investigator: Adam Marberger, DDS Jean Brown Research
  More Information

Publications:
Responsible Party: Novocol Pharmaceutical of Canada, Inc.
ClinicalTrials.gov Identifier: NCT01474382     History of Changes
Other Study ID Numbers: PHE-11-001
Study First Received: November 11, 2011
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novocol Pharmaceutical of Canada, Inc.:
OraVerse
Safety
Efficacy
Pediatric
Reversal of dental anesthesia

Additional relevant MeSH terms:
Phentolamine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014