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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pernix Theraputics LLC
ClinicalTrials.gov Identifier:
NCT02037893
First received: January 13, 2014
Last updated: November 19, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Acute Otitis Media
Drug: Antipyrine and Benzocaine otic solution
Drug: Antipyrine Otic Solution
Drug: Benzocaine Otic Solution
Drug: Placebo Otic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Pernix Theraputics LLC:

Primary Outcome Measures:
  • Face, Legs, Activity, Cry, Consolibility Scale (FLACC) or Faces Pain Scale Revised (FPS-R) [ Time Frame: 1 hour after a single dose ] [ Designated as safety issue: No ]
    Reduction of pain symptoms


Secondary Outcome Measures:
  • FLACC or FPS-R [ Time Frame: Dosing every 3 hours for 1 day ] [ Designated as safety issue: No ]
    Effect of dosing every 3 hours for 1 day in the reduction of pain symptoms over 3 days

  • FLACC or FPS-R [ Time Frame: Effect of dosing every 3 hours for 1 day ] [ Designated as safety issue: No ]
    The effect of dosing every 3 hours for 1 day on percent of subjects with complete or partial pain relief


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


Enrollment: 112
Study Start Date: November 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   2 Months to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 South
Salt Lake City, Utah, United States, 84121
FirstMed East
Salt lake City, Utah, United States, 84121
Foothill Family Clinic
Salt lake City, Utah, United States, 84109
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
  More Information

No publications provided

Responsible Party: Pernix Theraputics LLC
ClinicalTrials.gov Identifier: NCT02037893     History of Changes
Other Study ID Numbers: PNX-CL-001
Study First Received: January 13, 2014
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014