Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02044341
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Arbor Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE January 24, 2014
Last Update Posted Date April 8, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
Complete ear pain relief [ Time Frame: At or prior to 60 minutes post baseline dose ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02044341 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
  • time to complete pain relief (score of 0 on pain scales) [ Time Frame: 10, 20, 30, 45, and a60 minutes post baseline dose ]
    The time to complete pain relief (score of 0 on FAECC or FPS-R prior to any analgesic/antipyretic use), in minutes.
  • The proportion of subjects with complete ear pain relief [ Time Frame: at or prior to 10, 20, 30, 45, and 60 minutes post baseline dose ]
    The proportion of subjects with complete ear pain relief (score of 0 on FAECC or FPS-R prior to any analgesic/antipyretic use) 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 [ Time Frame: measured at 10, 20, 30, 45, and 60 minutes post baseline dose ]
  • Sum of pain intensity (SPID) using FPS-R and FAECC pain scores [ Time Frame: measured from baseline (pre-dose) to 60 minutes ]
  • Time from baseline to in-clinic use of analgesic/antipyretic to relief ear pain [ Time Frame: 60 Minutes ]
  • The number of subjects who receive analgesic/antipyretic medications for relief of ear pain during the clinic visit [ Time Frame: measured at or prior to 10, 20, 30, 45, and 60 minutes post baseline dose ]
  • Number of adverse events reported as a measure of safety and tolerability [ Time Frame: up to 30 days ]
    measured by treatment-emergent adverse events (AEs), concomitant medications, vital signs (pulse, temperature, and respiratory rate), abbreviated physical examination (head, ears, eyes, nose and throat and chest), external ear canal and pinna for signs of local tissue toxicity, such as rash, urticaria, local burning or stinging, skin discoloration, swelling, itching, and severe redness, and an assessment for signs of methemoglobinemia (i.e., unexplained bluish coloring of skin, fatigue, shortness of breath, failure to thrive, and headache).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 22, 2014)
  • Time from complete ear pain relief (score of 0 on FAECC or FPS-R) to a pain event using the home use data [ Time Frame: up to 4 Days (± 1) ]
    A pain event may include analgesic/antipyretic use, a FAECC score of >/= 5 or FPS-R score of >/= 6, or study withdrawal due to AOM, treatment, or the study itself
  • Relation between analgesic/antipyretic use and study medication use during the in-home period [ Time Frame: at or prior to 15, 30, and 60 minutes baseline study medication dose and up to 4 Days (± 1) ]
    Dates and times of analgesic/antipyretic use will be compared with the dates and times of home use of study medication to create the use or non-use outcome for each time point.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
Official Title  ICMJE A Phase 3, Multicenter, Placebo-controlled, Double-blind, Randomized Study to Compare the Efficacy and Safety of AR01 Otic Solution to a Placebo Solution for Relief of Pain in Acute Otitis Media Subjects Aged 2 Months to 19 Years
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Otitis Media
Intervention  ICMJE
  • Drug: AR01
    drops administered an needed for pain
    Other Name: benzocaine
  • Drug: Glycerin ear drops
    placebo drops administered for ear pain
    Other Name: placebo
Study Arms  ICMJE
  • Active Comparator: AR01 - Topical Otic Solution

    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.

    Intervention: Drug: AR01
  • Placebo Comparator: Glycerin ear drops

    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.

    Intervention: Drug: Glycerin ear drops
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2014)
304
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2014)
300
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02044341
Other Study ID Numbers  ICMJE AR01.006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arbor Pharmaceuticals, Inc.
Study Sponsor  ICMJE Arbor Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Laurence J Downey, MD Arbor Pharmaceuticals, LLC
PRS Account Arbor Pharmaceuticals, Inc.
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP