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Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media

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ClinicalTrials.gov Identifier: NCT02037893
Recruitment Status : Completed
First Posted : January 16, 2014
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pernix Theraputics LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acute Otitis Media
Interventions Drug: Antipyrine and Benzocaine otic solution
Drug: Antipyrine Otic Solution
Drug: Benzocaine Otic Solution
Drug: Placebo Otic solution
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Period Title: Overall Study
Started 32 25 27 28
Completed 32 25 26 28
Not Completed 0 0 1 0
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo Total
Hide Arm/Group Description

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Total of all reporting groups
Overall Number of Baseline Participants 32 25 27 28 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 25 participants 27 participants 28 participants 112 participants
4.4  (3.27) 4.4  (3.36) 4.5  (3.75) 3.5  (3.35) 4.2  (3.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 25 participants 27 participants 28 participants 112 participants
Female
13
  40.6%
10
  40.0%
11
  40.7%
10
  35.7%
44
  39.3%
Male
19
  59.4%
15
  60.0%
16
  59.3%
18
  64.3%
68
  60.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 25 participants 27 participants 28 participants 112 participants
Hispanic or Latino
9
  28.1%
6
  24.0%
5
  18.5%
6
  21.4%
26
  23.2%
Not Hispanic or Latino
23
  71.9%
19
  76.0%
21
  77.8%
22
  78.6%
85
  75.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   3.7%
0
   0.0%
1
   0.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 25 participants 27 participants 28 participants 112 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   3.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.9%
Black or African American
5
  15.6%
2
   8.0%
2
   7.4%
3
  10.7%
12
  10.7%
White
24
  75.0%
22
  88.0%
24
  88.9%
24
  85.7%
94
  83.9%
More than one race
2
   6.3%
1
   4.0%
1
   3.7%
1
   3.6%
5
   4.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 25 participants 27 participants 28 participants 112 participants
32 25 27 28 112
1.Primary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)
Hide Description

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Baseline and 1 hour after a single dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 30 24 22 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.3  (3.43) -5.0  (2.82) -4.6  (2.97) -4.9  (2.13)
2.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 15 min post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 31 24 24 28
Mean (Standard Error)
Unit of Measure: units on a scale
-3.6  (0.48) -3.6  (0.54) -3.4  (0.51) -3.8  (0.51)
3.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 30 min post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 30 24 24 27
Mean (Standard Error)
Unit of Measure: units on a scale
-3.9  (0.45) -4.3  (0.51) -4.4  (0.49) -4.8  (0.48)
4.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 3 hour post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 29 22 20 23
Mean (Standard Error)
Unit of Measure: units on a scale
-3.4  (0.47) -3.9  (0.53) -3.8  (0.50) -3.5  (0.50)
5.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 6 hour post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 27 21 19 19
Mean (Standard Error)
Unit of Measure: units on a scale
-3.4  (0.50) -4.0  (0.56) -3.9  (0.54) -3.8  (0.54)
6.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 12 hour post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 19 16 17 14
Mean (Standard Error)
Unit of Measure: units on a scale
-3.9  (0.53) -4.3  (0.60) -4.1  (0.57) -4.0  (0.57)
7.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 24 hour post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 29 20 21 22
Mean (Standard Error)
Unit of Measure: units on a scale
-5.5  (0.42) -4.4  (0.48) -4.2  (0.46) -4.6  (0.46)
8.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 36 hour post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 22 20 19 20
Mean (Standard Error)
Unit of Measure: units on a scale
-5.5  (0.42) -4.6  (0.48) -4.4  (0.46) -5.5  (0.45)
9.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 48 hour post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 30 23 22 26
Mean (Standard Error)
Unit of Measure: units on a scale
-5.4  (0.37) -5.3  (0.42) -4.7  (0.40) -5.9  (0.40)
10.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 60 hour post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 24 21 19 20
Mean (Standard Error)
Unit of Measure: units on a scale
-5.4  (0.33) -5.4  (0.37) -5.4  (0.36) -6.2  (0.36)
11.Secondary Outcome
Title Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose
Hide Description

The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.

The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.

The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.

Time Frame Change from Baseline to 72 hour post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description:

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Overall Number of Participants Analyzed 30 24 24 26
Mean (Standard Error)
Unit of Measure: units on a scale
-5.9  (0.29) -5.9  (0.33) -5.4  (0.32) -6.1  (0.32)
Time Frame Up to 120 hours after first dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Hide Arm/Group Description

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated

All-Cause Mortality
Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/25 (0.00%)      0/27 (0.00%)      0/28 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/25 (0.00%)      0/27 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Antipyrine and Benzocaine Otic Solution Antipyrine Otic Solution Benzocaine Otic Solution Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/32 (18.75%)      9/25 (36.00%)      4/27 (14.81%)      5/28 (17.86%)    
Ear and labyrinth disorders         
Ear pain *  0/32 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/28 (3.57%)  1
Hypoacisis *  0/32 (0.00%)  0 1/25 (4.00%)  1 0/27 (0.00%)  0 0/28 (0.00%)  0
Gastrointestinal disorders         
Diarrhea *  0/32 (0.00%)  0 1/25 (4.00%)  1 0/27 (0.00%)  0 0/28 (0.00%)  0
Nausea *  0/32 (0.00%)  0 1/25 (4.00%)  1 0/27 (0.00%)  0 0/28 (0.00%)  0
Vomiting *  1/32 (3.13%)  1 4/25 (16.00%)  4 1/27 (3.70%)  1 0/28 (0.00%)  0
General disorders         
Application site pain *  0/32 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1 0/28 (0.00%)  0
Pyrexia *  1/32 (3.13%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations         
Lice infestation *  1/32 (3.13%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 0/28 (0.00%)  0
Otitis Media *  0/32 (0.00%)  0 1/25 (4.00%)  1 0/27 (0.00%)  0 1/28 (3.57%)  1
Otitis Media acute *  0/32 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/28 (3.57%)  1
Upper respiratory tract infection *  0/32 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/28 (3.57%)  1
Viral rash *  0/32 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1 0/28 (0.00%)  0
Injury, poisoning and procedural complications         
Excoriation *  0/32 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1 0/28 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration *  0/32 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/28 (3.57%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia *  0/32 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/28 (3.57%)  1
Nervous system disorders         
Headache *  1/32 (3.13%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 0/28 (0.00%)  0
Somnolence *  1/32 (3.13%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough *  0/32 (0.00%)  0 1/25 (4.00%)  1 0/27 (0.00%)  0 0/28 (0.00%)  0
Pulmonary congestion *  1/32 (3.13%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 0/28 (0.00%)  0
Rhinorrhea *  0/32 (0.00%)  0 1/25 (4.00%)  1 0/27 (0.00%)  0 1/28 (3.57%)  1
Skin and subcutaneous tissue disorders         
Acne *  0/32 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1 0/28 (0.00%)  0
Pruritus *  0/32 (0.00%)  0 1/25 (4.00%)  1 1/27 (3.70%)  1 0/28 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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: Senior Director, Medical and Scientific Affairs
Organization: Pernix Therapeutics
Phone: 8007932145
Responsible Party: Pernix Theraputics LLC
ClinicalTrials.gov Identifier: NCT02037893     History of Changes
Other Study ID Numbers: PNX-CL-001
First Submitted: January 13, 2014
First Posted: January 16, 2014
Results First Submitted: July 3, 2018
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018