Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media

Pain Clinical Trial

Official title:

Phase 2, Multicenter, Placebo-controlled, Double-masked, Randomized Study to Demonstrate Reliability and Validity of FAECC Scale (Modified FLACC) to Evaluate Relief of Pain in Subjects With Acute Otitis Media Aged >/=2 Months to <5 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588535
• Other study ID #: AR01.004
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2012
• Last updated: April 13, 2015
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: March 2015
• Source: Arbor Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.

Description:

to assess the reliability and validity of the FAECC pain scale tool in children aged 2 months to 5 years with acute otitis media given AR01 or placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 4 Years

Eligibility

Inclusion Criteria:

• The patient has age in the interval 2 months = age < 5.00 years, signs and symptoms of AOM, and moderate to severe pain (current episode = 2 weeks duration). Moderate to severe pain is defined as a score of > or = 4 (on a scale of 0 - 10) for the FAECC scale as assessed by the primary assessor.

• The patient's parent/guardian must have read and signed the written informed consent prior to study participation.

• The patient is normally active and otherwise judged to be in good health on the basis of medical history and limited physical examination.

Exclusion Criteria:

• Patient has perforated tympanic membrane, history of a perforated tympanic membrane in the last 6 months, or if a perforated tympanic membrane could not be ruled out by speculum examination, impedance testing tympanometry, pneumatic otoscopy, or Valsalva maneuver. Patients who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately. Patients with tympanostomy tubes are not allowed.

• Patient has acute or chronic otitis externa.

• Patient has chronic otitis media (current episode = 2 weeks).

• Patient has seborrheic dermatitis involving the affected external ear canal or pinna.

• Patient has received any otic topical or systemic antibiotic within 14 days prior to study entry (topical or systemic antibiotics for acne will be allowed on a chronic basis for subjects who have been on a stable dose for at least 14 days prior to entry).

• Patient has received any topical drying agent or over-the-counter therapy for otitis media within 36 hours prior to enrollment.

• Patient has fever = 102.0 F (oral or equivalent).

• Patient has known hypersensitivity to the study drug or similar compounds including any of the inactive ingredients.

• Patient is receiving medication on a chronic basis for pain (including steroidal or non steroidal anti-inflammatory drugs) and has not been on a stable dose for at least 1 month prior to entry into the study.

• Patient has clinically significant mental illness (to be determined by the Investigator).

• Patient has been exposed to any investigational agent within 30 days prior to study entry.

• Patient has been previously enrolled in this study.

• Patient or caregiver (parent/guardian) has a condition the Investigator believes will interfere with the ability to provide consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.

• Patient has a glucose 6-phosphate dehydrogenase deficiency or is taking concomitant medications associated with methemoglobinemia (such as nitrates or nitrites; aniline dyes; or medications, including lidocaine, prilocaine, phenazopyridine hydrochloride [Pyridium], and others).

• Patient demonstrates clinical signs of anemia. The absolute amount of deoxygenated or abnormal hemoglobin (rather than its percentage) is required for cyanosis to be clinically evident. Patients with moderate-to-severe anemia may not appear cyanotic, even with elevated percentages of deoxygenated or abnormal hemoglobin.

• Patient has congenital (i.e., hereditary) methemoglobinemia.

• Patient has a recent history of acute gastroenteritis within 14 days prior to study entry. An association between methemoglobinemia and acute gastroenteritis in infants has been noted in several studies and may be due to acidosis from stool bicarbonate loss impairing the already immature function of the methemoglobin reductase system in these young patients.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Pain

Intervention

Drug:
• benzocaine
benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed
• placebo
placebo solution, five drops in affected ear canal each hour as needed

Locations

Country	Name	City	State
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	DiscoveReseach, Inc.	Bryan	Texas
United States	Research Across America	Carrollton	Texas
United States	ACCESS CLINICAL TRIALS, Inc. / Centennial Medical Center	Clarksville	Tennessee
United States	Research Across America	Dallas	Texas
United States	Odyssey Research	Fargo	North Dakota
United States	Prairie Fields Family Medicine/Clinical Research Advantage	Fremont	Nebraska
United States	Nda Baptist Clinic	Jonesboro	Arkansas
United States	Clinical Research Center	Las Vegas	Nevada
United States	COMMUNITY Medical Research	Miami Beach	Florida
United States	FIRSTMED	Salt Lake City	Utah
United States	Foothill Family Clinic	Salt Lake City	Utah
United States	Jordon River Family Medicine	South Jordan	Utah
United States	Dm Clinical Research	Tomball	Texas
United States	The Iowa Clinic, Pc	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Arbor Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consistency of primary assessor and caregiver FAECC scores using Pearson's correlation coefficient		up to 120 minutes after first dose and Day 4	No
Secondary	reduction in pain scores from predose to each post-dose time point		up to 120 minutes after each dose	No