Acute Otitis MediaPhase 3AR01006NCT02044341
Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
A Phase 3 study testing AR01 and Glycerin ear drops in people with Acute Otitis Media, run by Arbor Pharmaceuticals, Inc. at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- AR01 and Glycerin ear drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 29 sitesUnited States
- Study dates
- Dec 2013to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
White Oak Family Physicians
Asheboro, North Carolina, 27203
Kentucky Pediatric / Adult Research
Bardstown, Kentucky, 40004
So Cal Clinical Research Group
Bellflower, California, 90706
PMG Research of Bristol
Bristol, Tennessee, 37620
DiscoveResearch, Inc.
Byran, Texas, 77802
UNC Children's Hospital - General Pediatrics and Adolescent Medicine
Chapel Hill, North Carolina, 27516
Colorado Springs Health Partners /Clinical Research Advantag
Colorado Springs, Colorado, 80902
Research Across America - Dallas
Dallas, Texas, 75234
Hometown Urgent Care and Research Center (Dayton)
Dayton, Ohio, 45425
Southland Clinical Research Center
Fountain Valley, California, 92708
NEA Baptist Clinic
Jonesboro, Arkansas, 72401
J. Lewis Research, Inc/Jordan River Family Medicine
Jordan, Utah, 84095
Clinical Research Center
Las Vegas, Nevada, 89104
Brownsboro Park Pediatrics
Louisville, Kentucky, 40207
Madera Family Medical Group
Madera, California, 93637
Hennepin County Medical Center -Department of Emergency Medicine
Minneapolis, Minnesota, 55415
Pharma Research International, Inc
Naples, Florida, 34102
Michael W. Simon, MD, PSC
Nicholasville, Kentucky, 40356
FirstMed
Salt Lake City, Utah, 84109
Lewis Research, Inc/Foothill Family Clinic
Salt Lake City, Utah, 84109
Shoals Medical Trials, Inc.
Sheffield, Alabama, 35660
Virgo-Carter Pediatrics
Silver Spring, Maryland, 20910
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710
Wee Care Pediatrics
Syracuse, Utah, 84075
Pediatric Healthcare of Northwest Houston, PA
Tomball, Texas, 77375
SC Clinical Research, Inc
Tuscon, Arizona, 85745
Valley Stream Pediatrics
Valley Stream, New York, 11580
The Iowa Clinic, Pc
West Des Moines, Iowa, 50266
Heartland Research Associates, LLC
Wichita, Kansas, 67205
About this study
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
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.
Read the 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
- Being tested
- AR01, Glycerin ear drops
- Keywords
- Acute Otitis Media, Pain, Ear Pain, Ear Ache, Ear infection, middle ear infection
- Medical subject headings
- Otitis Media, Pain, Earache, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR01Drug
Also called benzocaine
drops administered an needed for pain
Glycerin ear dropsDrug
Also called placebo
placebo drops administered for ear pain
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Glycerin ear drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At or prior to 60 minutes post baseline dose
Secondary outcomes (7)
time to complete 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.
Measured: 10, 20, 30, 45, and a60 minutes post baseline dose
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.
Measured: 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: 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: measured from baseline (pre-dose) to 60 minutes
Time from baseline to in-clinic use of analgesic/antipyretic to relief ear pain
Measured: 60 Minutes
The number of subjects who receive analgesic/antipyretic medications for relief of ear pain during the clinic visit
Measured: 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
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).
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence J Downey, MD, Study chair, Arbor Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044341
- Sponsor's protocol ID
- AR01.006
- Acronym
- AR01006
- Status last verified
- Mar 2015
- First submitted
- 22 Jan 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02044341
- Acronym / sponsor ID
- AR01006 / AR01.006
- Conditions
- Acute Otitis Media
- Keywords
- Acute Otitis Media, Pain, Ear Pain, Ear Ache, Ear infection, middle ear infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR01 - Topical Otic Solution | Active comparator | Drug: AR01Topical 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. |
| Glycerin ear drops | Placebo comparator | Drug: Glycerin ear dropsTopical 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. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR01Also: benzocainedrops administered an needed for pain | Drug | AR01 - Topical Otic Solution |
| Glycerin ear dropsAlso: placeboplacebo drops administered for ear pain | Drug | Glycerin ear drops |
Primary outcome
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.
7 secondary outcomes
time to complete pain relief (score of 0 on pain scales)
Time frame: 10, 20, 30, 45, and a60 minutes post baseline dose
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence J Downey, MD study chair
Arbor Pharmaceuticals, LLC
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AR01 and Glycerin ear drops in people with Acute Otitis Media, run by Arbor Pharmaceuticals, Inc. at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ear pain relief (time frame: At or prior to 60 minutes post baseline dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.