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

Novocol Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Anesthesia, Reversal

Anesthesia, Local

Dental Anesthesia

Treatments

Drug: OraVerse

Other: Sham injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01474382

PHE-11-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

2 to 5 years old

Volunteers

Accepts Healthy Volunteers

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