Clinical trial NCT02037893: Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Otitis Media
Lead sponsor: Currax Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-01-16
Enrollment: 112
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)
timeFrame: Baseline and 1 hour after a single dose
Secondary outcomes:
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose
timeFrame: Change from Baseline to 15 min post first dose
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose
timeFrame: Change from Baseline to 30 min post first dose
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose
timeFrame: Change from Baseline to 3 hour post first dose
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose
timeFrame: Change from Baseline to 6 hour post first dose
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose
timeFrame: Change from Baseline to 12 hour post first dose
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose
timeFrame: Change from Baseline to 24 hour post first dose
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose
timeFrame: Change from Baseline to 36 hour post first dose
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose
timeFrame: Change from Baseline to 48 hour post first dose
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose
timeFrame: Change from Baseline to 60 hour post first dose
measure: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose
timeFrame: Change from Baseline to 72 hour post first dose
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: Bentonville
country: United States
facility: Childrens Investigational Research Program
state: Arkansas
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Bardstown
country: United States
facility: Kentucky Pediatric and Adult Research
state: Kentucky
city: Orangeburg
country: United States
facility: Carolina Ear, Nose and Throat Clinic
state: South Carolina
city: Salt Lake City
country: United States
facility: Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: FirstMed East
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: Jordan River Family Medicine
state: Utah
Study officials:
affiliation: Visions Clinical Research
name: Steven Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Desert Clinical Research
name: Gerald Shockey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foothill Family Clinic South
name: Shane Christensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Med East
name: Stephanie Plunkett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordan River Family Medcine
name: Katie Julien, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foothill Family Clinic
name: James Peterson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolina Ear, Nose and Throat Clinic
name: John Ansely, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kentucky Pediatric and Adult Research
name: James Hendrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Visions Clinical Research Boyton Beach
name: Amy Agua, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Childrens Investigational Research Program
name: Bryan Harvey, MD
role: PRINCIPAL_INVESTIGATOR
References: