Overview

This trial is active, not recruiting.

Condition anesthesia
Treatments tetracaine hcl 3% and oxymetazoline hcl 0.05%, tetracaine hcl 3%, placebo
Phase phase 3
Sponsor St. Renatus, LLC
Collaborator Triligent International
Start date August 2012
End date October 2012
Trial size 140 participants
Trial identifier NCT01660893, SR 3-01

Summary

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Tetracaine HCl 3% and oxymetazoline HCl 0.05%
tetracaine hcl 3% and oxymetazoline hcl 0.05% Kovacaine Mist
3 unilateral intranasal sprays per dose
(Experimental)
Tetracaine HCl 3%
tetracaine hcl 3%
3 unilateral intranasal sprays per dose
(Placebo Comparator)
Placebo
placebo
3 unilateral intranasal sprays per dose

Primary Outcomes

Measure
Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic (yes/no).
time frame: at 15 minutes with a 3 minute window

Secondary Outcomes

Measure
Intraoral soft-tissue anesthesia (yes/no) and the time to onset and duration of such soft-tissue anesthesia.
time frame: at 15 minutes with a 3 minute window
Heart Rate higher than 125 bpm
time frame: at any time within 120 minutes following drug administration
Heart Rate lower than 50 bpm
time frame: at any time within 120 minutes following drug administration
Increase from baseline in Systolic blood pressure greater than or equal to 25 mm Hg and to a value higher than 140 mm Hg
time frame: at any time within 120 minutes following drug administration
Decrease from baseline in Systolic blood pressure greater than or equal to 15 mm Hg and to a value lower than 90 mm Hg
time frame: at any time within 120 minutes following drug administration
Increase from baseline in Diastolic blood pressure greater than or equal to 15 mm Hg and to a value higher than 95 mm Hg
time frame: at any time within 120 minutes following drug administration
Decrease from baseline in Diastolic blood pressure greater than or equal to 10 mm Hg and to a value lower than 50 mm Hg
time frame: at any time within 120 minutes following drug administration
Maximum change from baseline in Heart Rate, Systolic blood pressure and Diastolic blood pressure
time frame: from baseline to 120 minutes following drug administration
The profile over time of Heart Rate, Systolic blood pressure and Diastolic blood pressure
time frame: from baseline to 120 minutes following drug administration
Alcohol Sniff Test
time frame: administered at approximately 24 hours after drug administration

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or female 18 years of age or older. - Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology. - Normal lip, nose, eyelid, and cheek sensation. - Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol. - Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure. - Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive. - Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive. Exclusion Criteria: - Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg). - Inadequately controlled active thyroid disease of any type. - Frequent nose bleeds (≥ 5 per month). - Having received dental care requiring a local anesthetic within the last 24 hours. - History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen). - History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives. - Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry. - Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.) - Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation. - Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure. - History of congenital or idiopathic methemoglobinemia

Additional Information

Official title A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults
Description The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure. A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by St. Renatus, LLC.