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

NCT02037893 | Completed Phase 2 Results

• 1 other identifier: PNX-CL-001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose

  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

  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

  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

  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

  Change from Baseline to 12 hour post first dose

Study Arms (4)

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

Drug: Antipyrine and Benzocaine otic solution; Drug: Placebo Otic solution

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

Drug: Antipyrine Otic Solution; Drug: Placebo Otic solution

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

Drug: Benzocaine Otic Solution; Drug: Placebo Otic solution

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

Drug: Placebo Otic solution

Interventions

Antipyrine and Benzocaine otic solution DRUG

antipyrine 54 mg and benzocaine 14 mg

Antipyrine and Benzocaine Otic solution

Antipyrine Otic Solution DRUG

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Antipyrine Otic Solution

Benzocaine Otic Solution DRUG

benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Benzocaine Otic Solution

Placebo Otic solution DRUG

Placebo otic solution will be glycerin that is dehydrated

Antipyrine Otic Solution; Antipyrine and Benzocaine Otic solution; Benzocaine Otic Solution; Placebo

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Currax Pharmaceuticals: lead

Study Sites (10)

Desert Clinical Research

Mesa, Arizona, 85213, United States

Location

Visions Clinical Research

Tucson, Arizona, 85712, United States

Location

Childrens Investigational Research Program

Bentonville, Arkansas, 72712, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Kentucky Pediatric and Adult Research

Bardstown, Kentucky, 40004, United States

Location

Carolina Ear, Nose and Throat Clinic

Orangeburg, South Carolina, 29118, United States

Location

Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

FirstMed East

Salt Lake City, Utah, 84121, United States

Location

Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Antipyrine

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Director, Medical and Scientific Affairs
• Organization: Pernix Therapeutics

egould@pernixtx.com

8007932145

Study Officials

• 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

  Childrens Investigational Research Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 16, 2014
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 7, 2024
• Results First Posted: August 31, 2018

Record last verified: 2018-08

Locations

US (10)