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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
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Pernix Theraputics LLC

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.

Condition or disease Intervention/treatment Phase
Acute Otitis Media Drug: Antipyrine and Benzocaine otic solution Drug: Antipyrine Otic Solution Drug: Benzocaine Otic Solution Drug: Placebo Otic solution Phase 2

Detailed 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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Four-arm, Randomized, Double-blind, Active and Placebo Controlled Study to Determine the Safety and Efficacy of a Combination Antupyrine and Benzocaine Otic Solution Compared With Antipyrine Otic Solution Alone, Benzocaine Otic Solution Alone and to Placebo Otic Solution to Relieve Pain Symptoms in Children With Acute Otitis Media.
Study Start Date : November 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: 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
Drug: Antipyrine and Benzocaine otic solution
Drug: Placebo Otic solution
Active Comparator: 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
Drug: Antipyrine Otic Solution
Drug: Placebo Otic solution
Active Comparator: 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
Drug: Benzocaine Otic Solution
Drug: Placebo Otic solution
Placebo Comparator: 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
Drug: Placebo Otic solution



Primary Outcome Measures :
  1. Face, Legs, Activity, Cry, Consolibility Scale (FLACC) or Faces Pain Scale Revised (FPS-R) [ Time Frame: 1 hour after a single dose ]
    Reduction of pain symptoms


Secondary Outcome Measures :
  1. FLACC or FPS-R [ Time Frame: Dosing every 3 hours for 1 day ]
    Effect of dosing every 3 hours for 1 day in the reduction of pain symptoms over 3 days

  2. FLACC or FPS-R [ Time Frame: Effect of dosing every 3 hours for 1 day ]
    The effect of dosing every 3 hours for 1 day on percent of subjects with complete or partial pain relief


Other Outcome Measures:
  1. Safety as assessed by Adverse Events [ Time Frame: 3 days after 1 day of treatment ]
    AEs to be assessed for a period of 3 days after 1 day of dosing.



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Ages Eligible for Study:   2 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037893


Locations
United States, Arizona
Desert Clinical Research
Mesa, Arizona, United States, 85213
Visions Clinical Research
Tuscon, Arizona, United States, 85712
United States, Arkansas
Childrens Investigational Research Program
Bentonville, Arkansas, United States, 72712
United States, Florida
Visions Clinical Research
Boyton Beach, Florida, United States, 33472
United States, Kentucky
Kentucky Pediatric and Adult Research
Bardstown, Kentucky, United States, 40004
United States, South Carolina
Carolina Ear, Nose and Throat Clinic
Orangeberg, South Carolina, United States, 29118
United States, Utah
Foothill Family Clinic
Salt lake City, Utah, United States, 84109
FirstMed East
Salt lake City, Utah, United States, 84121
Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
Jordan River Family Medicine
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
Pernix Theraputics LLC
Investigators
Principal Investigator: 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

Responsible Party: Pernix Theraputics LLC
ClinicalTrials.gov Identifier: NCT02037893     History of Changes
Other Study ID Numbers: PNX-CL-001
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Pharmaceutical Solutions
Benzocaine
Antipyrine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents