Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media

NCT02044341 | Completed Phase 3

• 1 other identifier: AR01.006
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 29

Brief Summary

Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The patient or caregiver will measure the amount of ear pain before and after the ear drops to establish if the medicated ear drops decrease the amount of pain more than the placebo ear drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be used up to 4 days, as needed for ear pain.

Conditions

Acute Otitis Media

Keywords

Acute Otitis Media; Pain; Ear Pain; Ear Ache; Ear infection; middle ear infection

Outcome Measures

Primary Outcomes (1)

• Complete ear pain relief

  The proportion of subjects with complete pain relief (score of 0 on Face, Activity, Ears, Cry, Consolability tool (FAECC) as measured by the Assigned Clinical Assessor or Faces Pain Scale-Revised (FPS-R) as measured by the subject prior to any analgesic/antipyretic use) at or prior to 60 minutes post baseline dose.

  At or prior to 60 minutes post baseline dose

Secondary Outcomes (7)

• time to complete pain relief (score of 0 on pain scales)

  10, 20, 30, 45, and a60 minutes post baseline dose

• The proportion of subjects with complete ear pain relief

  at or prior to 10, 20, 30, 45, and 60 minutes post baseline dose

• The percent change in FPS-R and FAECC pain scores from baseline to post dose scores

  measured at 10, 20, 30, 45, and 60 minutes post baseline dose

• Sum of pain intensity (SPID) using FPS-R and FAECC pain scores

  measured from baseline (pre-dose) to 60 minutes

• Time from baseline to in-clinic use of analgesic/antipyretic to relief ear pain

  60 Minutes

Other Outcomes (2)

• Time from complete ear pain relief (score of 0 on FAECC or FPS-R) to a pain event using the home use data

  up to 4 Days (± 1)

• Relation between analgesic/antipyretic use and study medication use during the in-home period

  at or prior to 15, 30, and 60 minutes baseline study medication dose and up to 4 Days (± 1)

Study Arms (2)

AR01 - Topical Otic Solution

ACTIVE COMPARATOR

Topical ear drops The dosing regimen is every hour as needed for ear pain, not to exceed 10 mL of solution per ear in a 24-hour period Children 2 Months to 12 Years: dispense five drops of study drug into the affected ear canal(s) each hour, as needed for ear pain, or Children 12 years to \<19 years: dispense 10 drops of study drug into the affected ear canal(s) each hour, as needed for ear pain.

Drug: AR01

Glycerin ear drops

PLACEBO COMPARATOR

Topical ear drops The dosing regimen is every hour as needed for ear pain, not to exceed 10 mL of solution per ear in a 24-hour period Children 2 Months to 12 Years: dispense five drops of study drug into the affected ear canal(s) each hour, as needed for ear pain, or Children 12 years to \<19 years: dispense 10 drops of study drug into the affected ear canal(s) each hour, as needed for ear pain.

Drug: Glycerin ear drops

Interventions

AR01 DRUG

drops administered an needed for pain

Also known as: benzocaine

AR01 - Topical Otic Solution

Glycerin ear drops DRUG

placebo drops administered for ear pain

Also known as: placebo

Glycerin ear drops

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects 2 mo. to \< 19 yrs of age, with signs and symptoms of AOM, with moderate to severe pain (current episode 2 wks duration). Moderate to severe pain is defined as a score of 5 (on a scale of 0 - 10) on the FAECC pain scale as evaluated by a trained clinical staff or 6 (on a scale of 0 - 10) on the FPS-R as evaluated by the subject. Moderate to severe pain criteria must be met at eligibility and the pre-dose pain assessment.
• Males or non-pregnant, non-lactating females.
• The subject's caregiver must have read and signed the written informed consent (including assent from subjects 18 yrs as applicable according to Investigational review board (IRB) guidelines) prior to study participation.
• Subjects 18 yrs old must have read and signed the written informed consent prior to study participation.
• Normally active and otherwise judged to be in good health on the basis of medical history and limited physical examination.
• Females of childbearing potential must have a urine pregnancy test at the randomization visit with negative results returned prior to randomization.

You may not qualify if:

• 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. Subjects who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately. Subjects with tympanostomy tubes are not allowed.
• Acute or chronic otitis externa.
• Chronic otitis media (refers to current episode 2 wks).
• Seborrheic dermatitis involving the affected external ear canal or pinna.
• Any otic, topical, or systemic antibiotic received 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).
• Any topical drying agent or over-the-counter therapy for otitis media received within 36 hrs prior to enrollment.
• Known hypersensitivity to drug or similar compounds including any of the inactive ingredients.
• Subjects receiving medication on a chronic basis for pain (including steroidal or non-steroidal anti-inflammatory drugs) who have not been on a stable dose for at least 1 month prior to entry into the study.
• Clinically significant mental illness that may interfere with the conduct of the study (determined by Investigator).
• Exposure to any investigational agent within 30 days prior to study entry.
• Previous enrollment in this study.
• Subject/caregiver has a condition the Investigator believes would interfere with the ability to provide consent or assent (age-appropriate) or comply with study instructions, or that might confound the interpretation of the study results, or put the subject at undue risk.
• Subject 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).
• Subject shows clinical signs of anemia. The absolute amount of deoxygenated or abnormal hemoglobin (rather than its percentage) is required for cyanosis to be clinically evident. Subjects with moderate-to-severe anemia may not appear cyanotic, even with elevated percentages of deoxygenated or abnormal hemoglobins.
• Subject has congenital (i.e., hereditary) methemoglobinemia.

Sponsors & Collaborators

• Arbor Pharmaceuticals, Inc.: lead

Study Sites (29)

Shoals Medical Trials, Inc.

Sheffield, Alabama, 35660, United States

Location

SC Clinical Research, Inc

Tuscon, Arizona, 85745, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

So Cal Clinical Research Group

Bellflower, California, 90706, United States

Location

Southland Clinical Research Center

Fountain Valley, California, 92708, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

Colorado Springs Health Partners /Clinical Research Advantag

Colorado Springs, Colorado, 80902, United States

Location

Pharma Research International, Inc

Naples, Florida, 34102, United States

Location

SCORE Physician Alliance, LLC

St. Petersburg, Florida, 33710, United States

Location

The Iowa Clinic, Pc

West Des Moines, Iowa, 50266, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Kentucky Pediatric / Adult Research

Bardstown, Kentucky, 40004, United States

Location

Brownsboro Park Pediatrics

Louisville, Kentucky, 40207, United States

Location

Michael W. Simon, MD, PSC

Nicholasville, Kentucky, 40356, United States

Location

Virgo-Carter Pediatrics

Silver Spring, Maryland, 20910, United States

Location

Hennepin County Medical Center -Department of Emergency Medicine

Minneapolis, Minnesota, 55415, United States

Location

Clinical Research Center

Las Vegas, Nevada, 89104, United States

Location

Valley Stream Pediatrics

Valley Stream, New York, 11580, United States

Location

White Oak Family Physicians

Asheboro, North Carolina, 27203, United States

Location

UNC Children's Hospital - General Pediatrics and Adolescent Medicine

Chapel Hill, North Carolina, 27516, United States

Location

Hometown Urgent Care and Research Center (Dayton)

Dayton, Ohio, 45425, United States

Location

PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

DiscoveResearch, Inc.

Byran, Texas, 77802, United States

Location

Research Across America - Dallas

Dallas, Texas, 75234, United States

Location

Pediatric Healthcare of Northwest Houston, PA

Tomball, Texas, 77375, United States

Location

J. Lewis Research, Inc/Jordan River Family Medicine

Jordan, Utah, 84095, United States

Location

FirstMed

Salt Lake City, Utah, 84109, United States

Location

Lewis Research, Inc/Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

Wee Care Pediatrics

Syracuse, Utah, 84075, United States

Location

MeSH Terms

Conditions

Otitis Media; Pain; Earache; Otitis

Interventions

Benzocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Laurence J Downey, MD

  Arbor Pharmaceuticals, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2015-03

Locations

US (29)