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

NCT ID: NCT02074007

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-06-30

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.

Detailed Description

The study involves the initial clinic visit, using the ear drops at home and keeping a diary about the ear pain experienced and medications taken. The patient will return to the clinic 4 days later for evaluation and to return the ear drops and diary. The clinic staff will call to follow-up about the patient's condition seven days after the initial visit.

Conditions

Acute Otitis Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AR01 - Topical Otic Solution

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

Group Type: ACTIVE_COMPARATOR

AR01

Intervention Type: DRUG

drops administered as needed for pain

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.

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: DRUG

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

Interventions

AR01

drops administered as needed for pain

Intervention Type: DRUG

Placebo Comparator

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

Intervention Type: DRUG

Other Intervention Names

benzocaine; Glycerin ear drops

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Subject has a recent history of acute gastroenteritis within 14 days prior to study entry.
• Subject exhibits clinical signs of methemoglobinemia, such as unexplained bluish coloring of skin, fatigue, shortness of breath, failure to thrive, and headache.
• Subjects 5 to <19 yrs old who are unable to satisfactorily complete FPS-R screening test.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arbor Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence J Downey, MD

Role: STUDY_CHAIR

Arbor Pharmaceuticals, Inc.

Locations

Clinical Research Consortium Arizona

Phoenix, Arizona, United States

Kern Allergy and Medical Research, Inc

Bakersfield, California, United States

Central California Research

Fresno, California, United States

Pharma Research International, Inc

Naples, Florida, United States

SCORE Physician Alliance, LLC

St. Petersburg, Florida, United States

Kentucky Pediatric / Adult Research

Bardstown, Kentucky, United States

Pioneer Clinical Research, LLC

Bellevue, Nebraska, United States

Omaha ENT Clinic

Omaha, Nebraska, United States

Children's Health Center / St. Elizabeth Medical Center

Utica, New York, United States

Valley Stream Pediatrics

Valley Stream, New York, United States

Haywood pediatric and Adolescent Medicine Group, PA

Clyde, North Carolina, United States

Sterling Research Group, LTD

Cinncinati, Ohio, United States

Central Ohio Clinical Research

Columbus, Ohio, United States

Urgent Care Specialists Hometown Urgent Care

Columbus, Ohio, United States

Carolina Ear, Nose & Throat Clinic

Orangeburg, South Carolina, United States

PMG Research of Bristol

Bristol, Tennessee, United States

Holston Medical Group

Kingsport, Tennessee, United States

Tanner Clinic

Layton, Utah, United States

Foothill Family Clinic South

Salt Lake City, Utah, United States

Heartland Research Associates LLC - Augusta

Salt Lake City, Utah, United States

Van Dorn Pediatrics

Alexandria, Virginia, United States

Countries

United States

Other Identifiers

AR01.007

Identifier Type: -

Identifier Source: org_study_id