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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02037893
Other study ID # PNX-CL-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2013
Est. completion date September 2014

Study information

Verified date August 2018
Source Pernix Theraputics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 2 Months to 12 Years
Eligibility Inclusion Criteria:

- Clinical Diagnosis of Acute Otitis Media

- Moderate to severe pain

- Normally active and in good health as determined by the PI

- Parent or legal guardian consent

- Caregiver available to complete diaries during study

Exclusion Criteria:

- History of or current Perforated tympanic membrane

- Tympanostomy tubes

- Acute or chronic otitis externa

- seborrheic dermatitis

- Received any otic topical or systemic antibiotic within 14 days of enrollment

- Receiving medication on a chronic basis for pain

- Known hypersensitivity to investigational product.

- clinical significant mental illness as determined by the PI

- Exposed to another investigational agent within 30 days before study entry. Any condition the PI believed will interfere with the ability to comply with all study procedures

- History of glucose 6-phosphate dehydrogenase deficiency

- History or currently anemic

- Congenital methemoglobinemia

- Recent history of acute gastroenteritis within 14 days of enrollment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Antipyrine and Benzocaine otic solution
antipyrine 54 mg and benzocaine 14 mg
Antipyrine Otic Solution
Antipyrine 54 mg and glycerine dehydrated to 1.0 mL
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

Locations

Country Name City State
United States Kentucky Pediatric and Adult Research Bardstown Kentucky
United States Childrens Investigational Research Program Bentonville Arkansas
United States Visions Clinical Research Boynton Beach Florida
United States Desert Clinical Research Mesa Arizona
United States Carolina Ear, Nose and Throat Clinic Orangeburg South Carolina
United States FirstMed East Salt Lake City Utah
United States Foothill Family Clinic Salt Lake City Utah
United States Foothill Family Clinic South Salt Lake City Utah
United States Jordan River Family Medicine South Jordan Utah
United States Visions Clinical Research Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Pernix Theraputics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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.
Baseline and 1 hour after a single dose
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.
Change from Baseline to 15 min post first dose
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.
Change from Baseline to 30 min post first dose
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.
Change from Baseline to 3 hour post first dose
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.
Change from Baseline to 6 hour post first dose
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.
Change from Baseline to 12 hour post first dose
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.
Change from Baseline to 24 hour post first dose
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.
Change from Baseline to 36 hour post first dose
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.
Change from Baseline to 48 hour post first dose
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.
Change from Baseline to 60 hour post first dose
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.
Change from Baseline to 72 hour post first dose
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