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

• 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: Currax Pharmaceuticals
• Information provided by (Responsible Party): Currax Pharmaceuticals

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

• Responsible Party: Currax Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02037893
• Other Study ID Numbers: PNX-CL-001
• First Posted: January 16, 2014
• Results First Posted: August 31, 2018
• Last Update Posted: August 31, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

Otitis; Otitis Media; Ear Diseases; Otorhinolaryngologic Diseases; Antipyrine; Benzocaine; Pharmaceutical Solutions; 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