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

NCT01474382 | Completed Phase 4 DMC

• 1 other identifier: PHE-11-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Dental Anesthesia; Anesthesia, Local; Anesthesia, Reversal

Keywords

OraVerse; Safety; Efficacy; Pediatric; Reversal of dental anesthesia

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of adverse events

  Up to 3 days

• Clinically significant changes in vital signs

  Blood pressure and pulse

  Up to 3 days

• Clinically significant changes in oral cavity assessments

  Up to 3 days

• Nerve injury

  Up to 3 days

• Analgesics required for intraoral pain

  Up to 3 days

Secondary Outcomes (4)

• incidence, severity and duration of intraoral pain as measured by W-B PRS

  Up to 3 days

• Time to normal function

  Up to 3 days

• Time to normal lip sensation

  Up to 3 days

• Time to normal tongue sensation

  Up to 3 days

Study Arms (2)

OraVerse

EXPERIMENTAL

OraVerse in doses of either 1/4, 1/2 or 1 cartridge (1.8mL)

Drug: OraVerse

Sham injection

SHAM COMPARATOR

Dentist simulates injection with dental syringe

Other: Sham injection

Interventions

OraVerse DRUG

1.8mL dental cartridge delivered in doses of either 1/4, 1/2 or 1 cartridge depending on subject weight

OraVerse

Sham injection OTHER

No drug administered, simulation of injection used in same manner as drug

Sham injection

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novocol Pharmaceutical of Canada, Inc.: lead

Study Sites (7)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

University of Pennsylvania School of Dental

Philadelphia, Pennsylvania, 19104-6030, United States

Location

University of Pittsburgh School of Dental Medicine

Pittsburgh, Pennsylvania, 15261, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Center for Pediatric Dentistry

Seattle, Washington, 98115, United States

Location

Related Publications (4)

• Hersh EV, Moore PA, Papas AS, Goodson JM, Navalta LA, Rogy S, Rutherford B, Yagiela JA; Soft Tissue Anesthesia Recovery Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. J Am Dent Assoc. 2008 Aug;139(8):1080-93. doi: 10.14219/jada.archive.2008.0311.

  PMID: 18682623 BACKGROUND

• Moore PA, Hersh EV, Papas AS, Goodson JM, Yagiela JA, Rutherford B, Rogy S, Navalta L. Pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with phentolamine mesylate. Anesth Prog. 2008 Summer;55(2):40-8. doi: 10.2344/0003-3006(2008)55[40:POLWEF]2.0.CO;2.

  PMID: 18547152 BACKGROUND

• Tavares M, Goodson JM, Studen-Pavlovich D, Yagiela JA, Navalta LA, Rogy S, Rutherford B, Gordon S, Papas AS; Soft Tissue Anesthesia Reversal Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in pediatric patients. J Am Dent Assoc. 2008 Aug;139(8):1095-104. doi: 10.14219/jada.archive.2008.0312.

  PMID: 18682624 BACKGROUND

• Laviola M, McGavin SK, Freer GA, Plancich G, Woodbury SC, Marinkovich S, Morrison R, Reader A, Rutherford RB, Yagiela JA. Randomized study of phentolamine mesylate for reversal of local anesthesia. J Dent Res. 2008 Jul;87(7):635-9. doi: 10.1177/154405910808700717.

  PMID: 18573982 BACKGROUND

MeSH Terms

Interventions

Phentolamine; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

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

Study Officials

• 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

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 18, 2011
• Study Start: February 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

US (7)