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

C

Currax Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Acute Otitis Media

Treatments

Drug: Benzocaine Otic Solution
Drug: Placebo Otic solution
Drug: Antipyrine and Benzocaine otic solution
Drug: Antipyrine Otic Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT02037893
PNX-CL-001

Details and patient eligibility

About

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.

Full 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).

Enrollment

112 patients

Sex

All

Ages

2 months to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

112 participants in 4 patient groups, including a placebo group

Antipyrine and Benzocaine Otic solution
Experimental group
Description:
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
Treatment:
Drug: Antipyrine and Benzocaine otic solution
Drug: Placebo Otic solution
Antipyrine Otic Solution
Active Comparator group
Description:
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
Treatment:
Drug: Antipyrine Otic Solution
Drug: Placebo Otic solution
Benzocaine Otic Solution
Active Comparator group
Description:
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
Treatment:
Drug: Placebo Otic solution
Drug: Benzocaine Otic Solution
Placebo
Placebo Comparator group
Description:
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
Treatment:
Drug: Placebo Otic solution

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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