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The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.
Reduction of pain symptoms will be measured by using the Face, Legs, Activity, Cry, Consolability Scale (FLACC) and the Faces pain Scale Revised (FPS-R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antipyrine and Benzocaine Otic solution | Experimental | 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 Otic Solution | Active Comparator | 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 |
|
| Benzocaine Otic Solution | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antipyrine and Benzocaine otic solution | Drug | antipyrine 54 mg and benzocaine 14 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) | 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. | Baseline and 1 hour after a single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Goldberg, MD | Visions Clinical Research | Principal Investigator |
| Gerald Shockey, MD | Desert Clinical Research | Principal Investigator |
| Shane Christensen, MD | Foothill Family Clinic South | Principal Investigator |
| Stephanie Plunkett, MD | First Med East | Principal Investigator |
| Katie Julien, MD | Jordan River Family Medcine | Principal Investigator |
| James Peterson, MD | Foothill Family Clinic | Principal Investigator |
| John Ansely, MD | Carolina Ear, Nose and Throat Clinic | Principal Investigator |
| James Hendrick, MD | Kentucky Pediatric and Adult Research | Principal Investigator |
| Amy Agua, MD | Visions Clinical Research Boyton Beach | Principal Investigator |
| Bryan Harvey, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Clinical Research | Mesa | Arizona | 85213 | United States | ||
| Visions Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antipyrine and Benzocaine Otic Solution | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Antipyrine Otic Solution | Drug | Antipyrine 54 mg and glycerine dehydrated to 1.0 mL |
|
| Benzocaine Otic Solution | Drug | benzocaine 14 mg and glycerine dehydrated to 1.0 mL |
|
| Placebo Otic solution | Drug | Placebo otic solution will be glycerin that is dehydrated |
|
| Change from Baseline to 15 min post first dose |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose | 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. | Change from Baseline to 30 min post first dose |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose | 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. | Change from Baseline to 3 hour post first dose |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose | 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. | Change from Baseline to 6 hour post first dose |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose | 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. | Change from Baseline to 12 hour post first dose |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose | 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. | Change from Baseline to 24 hour post first dose |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose | 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. | Change from Baseline to 36 hour post first dose |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose | 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. | Change from Baseline to 48 hour post first dose |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose | 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. | Change from Baseline to 60 hour post first dose |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose | 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. | Change from Baseline to 72 hour post first dose |
| Childrens Investigational Research Program |
| Principal Investigator |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Childrens Investigational Research Program | Bentonville | Arkansas | 72712 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33472 | United States |
| Kentucky Pediatric and Adult Research | Bardstown | Kentucky | 40004 | United States |
| Carolina Ear, Nose and Throat Clinic | Orangeburg | South Carolina | 29118 | United States |
| Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| FirstMed East | Salt Lake City | Utah | 84121 | United States |
| Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| FG001 |
| Antipyrine Otic Solution |
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 |
| FG002 | Benzocaine Otic Solution | 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 |
| FG003 | Placebo | 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 |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Antipyrine and Benzocaine Otic Solution | 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 |
| BG001 | Antipyrine Otic Solution | 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 |
| BG002 | Benzocaine Otic Solution | 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 |
| BG003 | Placebo | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) | 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. | Intent-to-Treat population | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 hour after a single dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 15 min post first dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 30 min post first dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 3 hour post first dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 6 hour post first dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 12 hour post first dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 24 hour post first dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 36 hour post first dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 48 hour post first dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 60 hour post first dose |
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| Secondary | Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 72 hour post first dose |
|
Up to 120 hours after first dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antipyrine and Benzocaine Otic Solution | 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 | 0 | 32 | 0 | 32 | 6 | 32 |
| EG001 | Antipyrine Otic Solution | 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 | 0 | 25 | 0 | 25 | 9 | 25 |
| EG002 | Benzocaine Otic Solution | 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 | 0 | 27 | 0 | 27 | 4 | 27 |
| EG003 | Placebo | 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 | 0 | 28 | 0 | 28 | 5 | 28 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Hypoacisis | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Application site pain | General disorders | Non-systematic Assessment |
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| Pyrexia | General disorders | Non-systematic Assessment |
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| Lice infestation | Infections and infestations | Non-systematic Assessment |
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| Otitis Media | Infections and infestations | Non-systematic Assessment |
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| Otitis Media acute | Infections and infestations | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Viral rash | Infections and infestations | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Medical and Scientific Affairs | Pernix Therapeutics | 8007932145 | egould@pernixtx.com |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| ID | Term |
|---|---|
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
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|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
|
|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
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|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
|
|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
|
|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
|
|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
|
|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
|
|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
|
|
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 |
| OG002 | Benzocaine Otic Solution | 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 |
| OG003 | Placebo | 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 |
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