Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)

NCT02074007 | Terminated Phase 3

• 1 other identifier: AR01.007
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 21

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 ear pain relief (score of 0 on pain scales)

  10, 20, 30, 45, and 60 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 differences (SPID) using FPS-R and FAECC pain scores

  scores at pre-dose and 60 minutes post dose

• 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 Use period at or prior to 15, 30, and 60 minutes

  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 5-10 drops every hour as needed for ear pain, not to exceed 10 mL of solution per ear in a 24-hour period

Drug: AR01

Placebo Comparator

PLACEBO COMPARATOR

Topical ear drops Glycerin ear drops-The dosing regimen is 5-10 drops every hour as needed for ear pain, not to exceed 10 mL of solution per ear in a 24-hour period.

Drug: Placebo Comparator

Interventions

AR01 DRUG

drops administered as needed for pain

Also known as: benzocaine

AR01 - Topical Otic Solution

Placebo Comparator DRUG

Glycerin ear drops (placebo) drops administered as needed for ear pain

Also known as: Glycerin ear drops

Placebo Comparator

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 acute otitis media (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 (21)

Clinical Research Consortium Arizona

Phoenix, Arizona, 85004, United States

Location

Kern Allergy and Medical Research, Inc

Bakersfield, California, 93301, United States

Location

Central California Research

Fresno, California, 93720, United States

Location

Pharma Research International, Inc

Naples, Florida, 34102, United States

Location

SCORE Physician Alliance, LLC

St. Petersburg, Florida, 33710, United States

Location

Kentucky Pediatric / Adult Research

Bardstown, Kentucky, 40004, United States

Location

Pioneer Clinical Research, LLC

Bellevue, Nebraska, 68005, United States

Location

Omaha ENT Clinic

Omaha, Nebraska, 68130, United States

Location

Children's Health Center / St. Elizabeth Medical Center

Utica, New York, 13502, United States

Location

Valley Stream Pediatrics

Valley Stream, New York, 11580, United States

Location

Haywood pediatric and Adolescent Medicine Group, PA

Clyde, North Carolina, 39721, United States

Location

Sterling Research Group, LTD

Cinncinati, Ohio, 45246, United States

Location

Central Ohio Clinical Research

Columbus, Ohio, 43207, United States

Location

Urgent Care Specialists Hometown Urgent Care

Columbus, Ohio, 43214, United States

Location

Carolina Ear, Nose & Throat Clinic

Orangeburg, South Carolina, 29118, United States

Location

PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Heartland Research Associates LLC - Augusta

Salt Lake City, Utah, 84121, United States

Location

Van Dorn Pediatrics

Alexandria, Virginia, 22302, 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, Inc.

  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 16, 2014
• First Posted: February 28, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (21)