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Dose-Escalation Safety and Pharmacokinetic Study of K305

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304316
First Posted: February 25, 2011
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ground Zero Pharmaceuticals
Rho, Inc.
Information provided by (Responsible Party):
St. Renatus, LLC
Results First Submitted: November 2, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Anesthesia
Intervention: Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Kovacaine Nasal Spray

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%


Participant Flow:   Overall Study
    Kovacaine Nasal Spray
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Kovacaine Nasal Spray

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%


Baseline Measures
   Kovacaine Nasal Spray 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.2  (7.45) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  50.0% 
Male      6  50.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   8.3% 
Not Hispanic or Latino      11  91.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   8.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   8.3% 
White      10  83.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax of Oxymetazoline   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]

2.  Primary:   Cmax of Tetracaine   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]

3.  Primary:   Cmax of PBBA   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]

4.  Primary:   Half Life of Oxymetazoline   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]

5.  Primary:   Half Life of Tetracaine   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]

6.  Primary:   Half Life of PBBA   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]

7.  Secondary:   Pulse Oximetry Maximum Change From Baseline   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]

8.  Secondary:   Diastolic BP Maximum Change From Baseline   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]

9.  Secondary:   Systolic BP Maximum Change From Baseline   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]

10.  Secondary:   Pulse Rate Maximum Change From Baseline   [ Time Frame: Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Elliot V. Hersh
Organization: University of Pennsylvania
phone: 215-898-9686
e-mail: evhersh@pobox.upenn.edu



Responsible Party: St. Renatus, LLC
ClinicalTrials.gov Identifier: NCT01304316     History of Changes
Other Study ID Numbers: SR 2-02
First Submitted: February 18, 2011
First Posted: February 25, 2011
Results First Submitted: November 2, 2016
Results First Posted: August 31, 2017
Last Update Posted: August 31, 2017