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

Sponsor

Arbor Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01588535

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain Otitis Media	Drug: benzocaine Drug: placebo	Phase 2

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: benzocaine solution ear drops	Drug: benzocaine benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed Other Names: Arbor otic AR01
Placebo Comparator: Placebo ear drops	Drug: placebo placebo solution, five drops in affected ear canal each hour as needed

Arm

Intervention/Treatment

Active Comparator: benzocaine solution

ear drops

Drug: benzocaine

benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed

Other Names:

Arbor otic

AR01

Placebo Comparator: Placebo

ear drops

Drug: placebo

placebo solution, five drops in affected ear canal each hour as needed

Outcome Measures

Primary Outcome Measures

Consistency of primary assessor and caregiver FAECC scores using Pearson's correlation coefficient [up to 120 minutes after first dose and Day 4]

Secondary Outcome Measures

reduction in pain scores from predose to each post-dose time point [up to 120 minutes after each dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nda Baptist Clinic	Jonesboro	Arkansas	United States	72401
2	COMMUNITY Medical Research	Miami Beach	Florida	United States	33141
3	The Iowa Clinic, Pc	West Des Moines	Iowa	United States	50266
4	Kentucky Pediatric/Adult Research	Bardstown	Kentucky	United States	40004
5	Prairie Fields Family Medicine/Clinical Research Advantage	Fremont	Nebraska	United States	68025
6	Clinical Research Center	Las Vegas	Nevada	United States	89104
7	Odyssey Research	Fargo	North Dakota	United States	58104
8	ACCESS CLINICAL TRIALS, Inc. / Centennial Medical Center	Clarksville	Tennessee	United States	37203
9	DiscoveReseach, Inc.	Bryan	Texas	United States	77082
10	Research Across America	Carrollton	Texas	United States	75010
11	Research Across America	Dallas	Texas	United States	75234
12	Dm Clinical Research	Tomball	Texas	United States	77375
13	Foothill Family Clinic	Salt Lake City	Utah	United States	84109
14	FIRSTMED	Salt Lake City	Utah	United States	84121
15	Jordon River Family Medicine	South Jordan	Utah	United States	84095