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Trial record 77 of 433 for:    OTITIS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02037893
Recruitment Status : Completed
First Posted : January 16, 2014
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Currax Pharmaceuticals

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).

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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 Antipyrine 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
antipyrine 54 mg and benzocaine 14 mg

Drug: Placebo Otic solution
Placebo otic solution will be glycerin that is dehydrated

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
Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Drug: Placebo Otic solution
Placebo otic solution will be glycerin that is dehydrated

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
benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Drug: Placebo Otic solution
Placebo otic solution will be glycerin that is dehydrated

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
Placebo otic solution will be glycerin that is dehydrated




Primary Outcome Measures :
  1. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) [ Time Frame: Baseline and 1 hour after a single 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.



Secondary Outcome Measures :
  1. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose [ Time Frame: Change from Baseline to 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.


  2. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose [ Time Frame: Change from Baseline to 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.


  3. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose [ Time Frame: Change from Baseline to 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.


  4. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose [ Time Frame: Change from Baseline to 6 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.


  5. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose [ Time Frame: Change from Baseline to 12 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.


  6. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose [ Time Frame: Change from Baseline to 24 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.


  7. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose [ Time Frame: Change from Baseline to 36 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.


  8. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose [ Time Frame: Change from Baseline to 48 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.


  9. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose [ Time Frame: Change from Baseline to 60 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.


  10. Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose [ Time Frame: Change from Baseline to 72 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.




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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
Layout table for location information
United States, Arizona
Desert Clinical Research
Mesa, Arizona, United States, 85213
Visions Clinical Research
Tucson, Arizona, United States, 85712
United States, Arkansas
Childrens Investigational Research Program
Bentonville, Arkansas, United States, 72712
United States, Florida
Visions Clinical Research
Boynton 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
Orangeburg, 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
Currax Pharmaceuticals
Investigators
Layout table for investigator information
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

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Responsible Party: Currax Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02037893     History of Changes
Other Study ID Numbers: PNX-CL-001
First Posted: January 16, 2014    Key Record Dates
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Antipyrine
Benzocaine
Pharmaceutical Solutions
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents