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

NCT01588535 | Completed Phase 2

• 1 other identifier: AR01.004
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 15

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.

Conditions

Pain; Otitis Media

Keywords

pain; pain measurement; ear, middle; otitis media

Outcome Measures

Primary Outcomes (1)

• Consistency of primary assessor and caregiver FAECC scores using Pearson's correlation coefficient

  up to 120 minutes after first dose and Day 4

Secondary Outcomes (1)

• reduction in pain scores from predose to each post-dose time point

  up to 120 minutes after each dose

Study Arms (2)

benzocaine solution

ACTIVE COMPARATOR

ear drops

Drug: benzocaine

Placebo

PLACEBO COMPARATOR

ear drops

Drug: placebo

Interventions

benzocaine DRUG

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

Also known as: Arbor otic, AR01

benzocaine solution

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 2 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arbor Pharmaceuticals, Inc.: lead

Study Sites (15)

Nda Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

COMMUNITY Medical Research

Miami Beach, Florida, 33141, United States

Location

The Iowa Clinic, Pc

West Des Moines, Iowa, 50266, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Prairie Fields Family Medicine/Clinical Research Advantage

Fremont, Nebraska, 68025, United States

Location

Clinical Research Center

Las Vegas, Nevada, 89104, United States

Location

Odyssey Research

Fargo, North Dakota, 58104, United States

Location

ACCESS CLINICAL TRIALS, Inc. / Centennial Medical Center

Clarksville, Tennessee, 37203, United States

Location

DiscoveReseach, Inc.

Bryan, Texas, 77082, United States

Location

Research Across America

Carrollton, Texas, 75010, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Dm Clinical Research

Tomball, Texas, 77375, United States

Location

Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

FIRSTMED

Salt Lake City, Utah, 84121, United States

Location

Jordon River Family Medicine

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Conditions

Pain; Otitis Media

Interventions

Benzocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Laurence Downey, MD

  Arbor Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 1, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 4, 2015

Record last verified: 2015-03

Locations

US (15)