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Trial record 79 of 448 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

Tracking Information
First Submitted Date  ICMJE January 13, 2014
First Posted Date  ICMJE January 16, 2014
Results First Submitted Date  ICMJE July 3, 2018
Results First Posted Date  ICMJE August 31, 2018
Last Update Posted Date August 31, 2018
Study Start Date  ICMJE November 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 14, 2014)
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.
 
Descriptive Information
Brief Title  ICMJE Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Otitis Media
Intervention  ICMJE
  • Drug: Antipyrine and Benzocaine otic solution
    antipyrine 54 mg and benzocaine 14 mg
  • Drug: Antipyrine Otic Solution
    Antipyrine 54 mg and glycerine dehydrated to 1.0 mL
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Intervention: Drug: Placebo Otic solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2014)
112
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2014)
160
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02037893
Other Study ID Numbers  ICMJE PNX-CL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Currax Pharmaceuticals
Study Sponsor  ICMJE Currax Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Currax Pharmaceuticals
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP