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Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth

Information source: St. Renatus, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia

Intervention: Tetracaine HCl 3% and oxymetazoline HCl 0.05% (Drug); Tetracaine HCl 3% (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: St. Renatus, LLC

Official(s) and/or principal investigator(s):
Paul A. Moore, DMD/PhD/MPH, Study Director, Affiliation: University of Pittsburgh

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.

Clinical Details

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

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: Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic (yes/no).

Secondary outcome:

Intraoral soft-tissue anesthesia (yes/no) and the time to onset and duration of such soft-tissue anesthesia.

Heart Rate higher than 125 bpm

Heart Rate lower than 50 bpm

Increase from baseline in Systolic blood pressure greater than or equal to 25 mm Hg and to a value higher than 140 mm Hg

Decrease from baseline in Systolic blood pressure greater than or equal to 15 mm Hg and to a value lower than 90 mm Hg

Increase from baseline in Diastolic blood pressure greater than or equal to 15 mm Hg and to a value higher than 95 mm Hg

Decrease from baseline in Diastolic blood pressure greater than or equal to 10 mm Hg and to a value lower than 50 mm Hg

Maximum change from baseline in Heart Rate, Systolic blood pressure and Diastolic blood pressure

The profile over time of Heart Rate, Systolic blood pressure and Diastolic blood pressure

Alcohol Sniff Test

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

University of Maryland, Baltimore, Baltimore, Maryland 20740, United States

Family and Cosmetic Dentistry, Salt Lake City, Utah 84124, United States

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

Additional Information

Starting date: August 2012
Last updated: May 15, 2015

Page last updated: August 23, 2015

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