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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arbor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01588535
First received: April 27, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Pain
Otitis Media
Drug: benzocaine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Arbor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Consistency of primary assessor and caregiver FAECC scores using Pearson's correlation coefficient [ Time Frame: up to 120 minutes after first dose and Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduction in pain scores from predose to each post-dose time point [ Time Frame: up to 120 minutes after each dose ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: benzocaine solution Drug: benzocaine
benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed
Other Name: Arbor otic
Placebo Comparator: Placebo Drug: placebo
placebo solution, five drops in affected ear canal each hour as needed
Other Name: Arbor Otic

  Eligibility

Ages Eligible for Study:   2 Months to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588535

Locations
United States, Arkansas
Nda Baptist Clinic
Jonesboro, Arkansas, United States, 72401
United States, Florida
COMMUNITY Medical Research
Miami Beach, Florida, United States, 33141
United States, Iowa
The Iowa Clinic, Pc
West Des Moines, Iowa, United States, 50266
United States, Kentucky
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
United States, Nebraska
Prairie Fields Family Medicine/Clinical Research Advantage
Fremont, Nebraska, United States, 68025
United States, Nevada
Clinical Research Center
Las Vegas, Nevada, United States, 89104
United States, North Dakota
Odyssey Research
Fargo, North Dakota, United States, 58104
United States, Tennessee
ACCESS CLINICAL TRIALS, Inc. / Centennial Medical Center
Clarksville, Tennessee, United States, 37203
United States, Texas
DiscoveReseach, Inc.
Bryan, Texas, United States, 77082
Research Across America
Carrollton, Texas, United States, 75010
Research Across America
Dallas, Texas, United States, 75234
Dm Clinical Research
Tomball, Texas, United States, 77375
United States, Utah
Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
FIRSTMED
Salt Lake City, Utah, United States, 84121
Jordon River Family Medicine
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
Arbor Pharmaceuticals, Inc.
Investigators
Study Director: Laurence Downey, MD Arbor Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Arbor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01588535     History of Changes
Other Study ID Numbers: AR01.004
Study First Received: April 27, 2012
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Arbor Pharmaceuticals, Inc.:
pain
pain measurement
ear, middle
otitis media

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Benzocaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014