Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)
Primary Purpose
Acute Otitis Media
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AR01
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Media focused on measuring Acute Otitis Media, Pain, Ear Pain, Ear Ache, Ear infection, middle ear infection
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.
Sites / Locations
- Clinical Research Consortium Arizona
- Kern Allergy and Medical Research, Inc
- Central California Research
- Pharma Research International, Inc
- SCORE Physician Alliance, LLC
- Kentucky Pediatric / Adult Research
- Pioneer Clinical Research, LLC
- Omaha ENT Clinic
- Children's Health Center / St. Elizabeth Medical Center
- Valley Stream Pediatrics
- Haywood pediatric and Adolescent Medicine Group, PA
- Sterling Research Group, LTD
- Central Ohio Clinical Research
- Urgent Care Specialists Hometown Urgent Care
- Carolina Ear, Nose & Throat Clinic
- PMG Research of Bristol
- Holston Medical Group
- Tanner Clinic
- Foothill Family Clinic South
- Heartland Research Associates LLC - Augusta
- Van Dorn Pediatrics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
AR01 - Topical Otic Solution
Placebo Comparator
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
time to complete ear pain relief (score of 0 on pain scales)
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
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
Sum of pain intensity differences (SPID) using FPS-R and FAECC pain scores
Time from baseline to in-clinic use of analgesic/antipyretic to relief ear pain
The number of subjects who receive analgesic/antipyretic medications for relief of ear pain during the clinic visit
Number of adverse events reported as a measure of safety and tolerability
Full Information
NCT ID
NCT02074007
First Posted
January 16, 2014
Last Updated
January 23, 2017
Sponsor
Arbor Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02074007
Brief Title
Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
primary outcome measure not met
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbor Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media
Keywords
Acute Otitis Media, Pain, Ear Pain, Ear Ache, Ear infection, middle ear infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AR01 - Topical Otic Solution
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AR01
Other Intervention Name(s)
benzocaine
Intervention Description
drops administered as needed for pain
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Other Intervention Name(s)
Glycerin ear drops
Intervention Description
Glycerin ear drops (placebo) drops administered as needed for ear pain
Primary Outcome Measure Information:
Title
Complete ear pain relief
Description
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.
Time Frame
At or prior to 60 minutes post baseline dose
Secondary Outcome Measure Information:
Title
time to complete ear pain relief (score of 0 on pain scales)
Description
The time to complete pain relief (score of 0 on FAECC or FPS-R prior to any analgesic/antipyretic use), in minutes.
Time Frame
10, 20, 30, 45, and 60 minutes post baseline dose
Title
The proportion of subjects with complete ear pain relief
Description
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.
Time Frame
at or prior to 10, 20, 30, 45, and 60 minutes post baseline dose
Title
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
Title
Sum of pain intensity differences (SPID) using FPS-R and FAECC pain scores
Time Frame
scores at pre-dose and 60 minutes post dose
Title
Time from baseline to in-clinic use of analgesic/antipyretic to relief ear pain
Time Frame
60 minutes
Title
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
Title
Number of adverse events reported as a measure of safety and tolerability
Time Frame
up to 30 days
Other Pre-specified Outcome Measures:
Title
Time from complete ear pain relief (score of 0 on FAECC or FPS-R) to a pain event using the home use data
Description
A pain event may include any or all of the following: analgesic/antipyretic use, a FAECC score ≥5 or FPS-R score ≥6, and study withdrawal due to AOM, treatment, or the study itself.
Time Frame
up to 4 Days (± 1)
Title
Relation between Analgesic/antipyretic use and study medication use during the In-Home Use period at or prior to 15, 30, and 60 minutes
Description
Dates and times of analgesic/antipyretic use from 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.
Time Frame
at or prior to 15, 30, and 60 minutes baseline study medication dose and up to 4 Days (± 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence J Downey, MD
Organizational Affiliation
Arbor Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Research Consortium Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Kern Allergy and Medical Research, Inc
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Central California Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Pharma Research International, Inc
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
SCORE Physician Alliance, LLC
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Kentucky Pediatric / Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Pioneer Clinical Research, LLC
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Omaha ENT Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Children's Health Center / St. Elizabeth Medical Center
City
Utica
State/Province
New York
ZIP/Postal Code
13502
Country
United States
Facility Name
Valley Stream Pediatrics
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11580
Country
United States
Facility Name
Haywood pediatric and Adolescent Medicine Group, PA
City
Clyde
State/Province
North Carolina
ZIP/Postal Code
39721
Country
United States
Facility Name
Sterling Research Group, LTD
City
Cinncinati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Central Ohio Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Urgent Care Specialists Hometown Urgent Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Carolina Ear, Nose & Throat Clinic
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
PMG Research of Bristol
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Tanner Clinic
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Heartland Research Associates LLC - Augusta
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Van Dorn Pediatrics
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22302
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)
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