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Open-Label Study to Evaluate The Efficacy And Recommended Dosing Regimen Of Kovacaine Mist Administered Unilaterally For Anesthetizing Maxillary Teeth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Renatus, LLC
ClinicalTrials.gov Identifier:
NCT01479517
First received: November 22, 2011
Last updated: May 28, 2013
Last verified: May 2013

November 22, 2011
May 28, 2013
January 2012
April 2012   (final data collection date for primary outcome measure)
  • Cohort 1: The proportion of subjects receiving Kovacaine Mist who do not require rescue anesthesia during the operative dental procedure performed on a tooth in the range of 4 to 13. [ Time Frame: at 15 minutes, with +10 minute window ] [ Designated as safety issue: No ]
  • Cohort 1: The proportion of subjects receiving Kovacaine Mist who do not require rescue anesthesia during the operative dental procedure performed on tooth 3 or 14. [ Time Frame: 15 minutes, with +10 minute window ] [ Designated as safety issue: No ]
  • Cohort 2&3: The proportion of subjects receiving Kovacaine Mist who do not require rescue anesthesia during the operative dental procedure performed on a tooth in the range of 4 to 13. [ Time Frame: at 10 minutes, with +5 minute window ] [ Designated as safety issue: No ]
  • The proportion of subjects receiving Kovacaine Mist who do not require rescue anesthesia during the operative dental procedure performed on a tooth in the range of 4 to 13. [ Time Frame: at 15 minutes, with +10 minute window ] [ Designated as safety issue: No ]
  • The proportion of subjects receiving Kovacaine Mist who do not require rescue anesthesia during the operative dental procedure performed on tooth 3 or 14. [ Time Frame: 15 minutes, with +10 minute window ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01479517 on ClinicalTrials.gov Archive Site
  • The incidence of subjects receiving Kovacaine Mist with changes in systolic and diastolic blood pressure exceeding +/- 25% of preoperative measurements values. [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • The incidence of subjects receiving Kovacaine Mist with adverse changes in the naris airway. [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • The incidence of minor expected drug reactions after administration of Kovacaine Mist. [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • The proportion of subjects giving a positive response to evaluation question for subjective numbness assessment (SNA) after the procedure is completed. [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • The proportion of subjects receiving Kovacaine Mist with a global discomfort assessment of no more than mild discomfort measured at completion of an operative dental procedure (or immediately prior to receiving the rescue anesthetic) [ Time Frame: Within 60 minutes ] [ Designated as safety issue: No ]
  • The incidence of subjects receiving Kovacaine Mist with changes in systolic and diastolic blood pressure exceeding +/- 25% of preoperative measurements values. [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • The incidence of subjects receiving Kovacaine Mist with adverse changes in the nares airways. [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • The incidence of minor expected drug reactions after administration of Kovacaine Mist. [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • The proportion of subjects giving a positive response to evaluation question for subjective numbness assessment (SNA) after spray 4. [ Time Frame: 12 minutes ] [ Designated as safety issue: No ]
  • The proportion of subjects giving a positive response to evaluation question for subjective numbness assessment (SNA) after the procedure is completed. [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Open-Label Study to Evaluate The Efficacy And Recommended Dosing Regimen Of Kovacaine Mist Administered Unilaterally For Anesthetizing Maxillary Teeth
A Phase II, Single-Site, Open-Label Clinical Trial To Evaluate The Efficacy And Recommended Dosing Regimen Of Kovacaine Mist Administered Unilaterally For Anesthetizing Maxillary Teeth In Healthy Dental Patients

The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary teeth for dental procedures.

This is a Phase II single-center, open-label clinical trial with three dosing regimens, designed to determine the efficacy and optimal dose of the Kovacaine Mist intranasal delivery system for inducing pulpal anesthesia of maxillary teeth numbers 4-13 (maxillary right second premolar to maxillary left second premolar). Kovacaine will be administered intranasally on the same side of the midline as the tooth on which the procedure will be performed in three dosing cohorts [four 100 μL, two 200 μL, or one 200 μL spray(s)] of 10 subjects each. The first cohort receiving 4 sprays will be completed before initiating study of the remaining two cohorts, which will be treated using a randomized, parallel-group design. Administration: Subjects in the 4- and 2-spray cohorts will be administered the same total dose of 12 mg tetracaine HCl/0.2 mg oxymetazoline HCl. The 4-spray cohort will be treated with a sequence of four 100-μL sprays at intervals of 4 minutes. The 2-spray cohort will be treated with a sequence of two 200 μL sprays 4 minutes apart. The 1-spray cohort will be administered one 200 μL spray, a total dose of 6 mg tetracaine HCl/0.1 mg oxymetazoline HCl, which is half the dose of the 2-spray cohort. Rescue: If the study drug does not provide sufficient anesthesia to allow for completion of the dental procedure, a rescue injection of articaine will be administered.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Anesthesia
  • Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%
    Nasal spray with 0.1 mL per spray. Dose = 4 sprays of study drug per subject delivered at 4-minute intervals.
  • Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%
    Nasal spray with 0.2 mL per spray. Dose = 2 sprays of study drug per subject delivered at 4-minute intervals.
  • Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%
    Nasal spray with 0.2 mL per spray. Dose = 1 spray of study drug per subject.
  • Experimental: Kovacaine Mist, 4 sprays unilateral
    Intervention: Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%
  • Experimental: Kovacaine Mist, 2 sprays unilateral
    Intervention: Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%
  • Experimental: Kovacaine Mist, 1 spray unilateral
    Intervention: Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects who are 18 years of age or older;
  • requiring an operative restorative procedure on a single maxillary tooth with no evidence of pulpal pathology requiring local anesthesia;
  • having normal lip, nose, eyelid, and cheek sensations;
  • able to understand and sign the informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol;
  • having patency of naris on same side of head as tooth requiring the dental procedure.

Exclusion Criteria:

  • Inadequately controlled hypertension (blood pressures greater than 150/90) or untreated coronary heart disease;
  • inadequately controlled thyroid disease including Hashimoto's thyroiditis and partial thyroidectomy;
  • having frequent nose bleeds (10 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, benzocaine, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreens);
  • history of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives; history of taking a monoamine oxidase inhibitor within the past 3 weeks;
  • are nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females will be required to take a urine pregnancy test on the day of but prior to study drug administration to rule out pregnancy);
  • having used any investigational drug and/or participated in any clinical research trial within 30 days of baseline
  • enlarged prostate
  • narrow angle glaucoma
  • use of oxymetazoline or phenylephrine nasal spray or oral decongestant on the day of the study
  • congenital or idiopathic methemoglobinemia
  • diabetes mellitus
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01479517
SR 2-05
No
St. Renatus, LLC
St. Renatus, LLC
Not Provided
Principal Investigator: Christina Sletten, DDS Rock Dental Clinic
St. Renatus, LLC
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP