DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Novocol Pharmaceutical of Canada, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dental Anesthesia; Anesthesia, Local; Anesthesia, Reversal

Intervention: OraVerse (Drug); Sham injection (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Novocol Pharmaceutical of Canada, Inc.

Official(s) and/or principal investigator(s):
Paul Moore, DMD,PhD,MPH, Principal Investigator, Affiliation: University of Pittsburgh School of Dental Medicine
Elliot Hersh, DMD,MS,PhD, Principal Investigator, Affiliation: University of Pennsylvania
Joel Berg, DDS,MS, Principal Investigator, Affiliation: Seattle Children's Hospital
Judith Chin, DDS,MS, Principal Investigator, Affiliation: Indiana University
Brent Lin, DMD, Principal Investigator, Affiliation: University of California, San Francisco
Paul Casamassimo, MS,DDS, Principal Investigator, Affiliation: Nationwide Children's Hospital
Adam Marberger, DDS, Principal Investigator, Affiliation: Jean Brown Research

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Incidence and severity of adverse events

Clinically significant changes in vital signs

Clinically significant changes in oral cavity assessments

Nerve injury

Analgesics required for intraoral pain

Secondary outcome:

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

Time to normal function

Time to normal lip sensation

Time to normal tongue sensation

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

Minimum age: 2 Years. Maximum age: 5 Years. Gender(s): Both.

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

Locations and Contacts

University of California, San Francisco, San Francisco, California 94143, United States

Indiana University School of Dentistry, Indianapolis, Indiana 46202, United States

Nationwide Children's Hospital, Columbus, Ohio 43205, United States

University of Pennsylvania School of Dental, Philadelphia, Pennsylvania 19104-6030, United States

University of Pittsburgh School of Dental Medicine, Pittsburgh, Pennsylvania 15261, United States

Jean Brown Research, Salt Lake City, Utah 84124, United States

Center for Pediatric Dentistry, Seattle`, Washington 98115, United States

Additional Information

Related publications:

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.

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.

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. Erratum in: J Am Dent Assoc. 2008 Oct;139(10):1312.

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.

Starting date: February 2012
Last updated: August 28, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017