Acute Otitis MediaPhase 3NCT02074007
Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)
A Phase 3 study testing AR01 in people with Acute Otitis Media, run by Arbor Pharmaceuticals, Inc. at 21 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 21 sitesUnited States
- Study dates
- Dec 2013to Jun 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 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.
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
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Van Dorn Pediatrics
Alexandria, Virginia, 22302
Kern Allergy and Medical Research, Inc
Bakersfield, California, 93301
Kentucky Pediatric / Adult Research
Bardstown, Kentucky, 40004
Pioneer Clinical Research, LLC
Bellevue, Nebraska, 68005
PMG Research of Bristol
Bristol, Tennessee, 37620
Sterling Research Group, LTD
Cinncinati, Ohio, 45246
Haywood pediatric and Adolescent Medicine Group, PA
Clyde, North Carolina, 39721
Central Ohio Clinical Research
Columbus, Ohio, 43207
Urgent Care Specialists Hometown Urgent Care
Columbus, Ohio, 43214
Central California Research
Fresno, California, 93720
Holston Medical Group
Kingsport, Tennessee, 37660
Tanner Clinic
Layton, Utah, 84041
Pharma Research International, Inc
Naples, Florida, 34102
Omaha ENT Clinic
Omaha, Nebraska, 68130
Carolina Ear, Nose & Throat Clinic
Orangeburg, South Carolina, 29118
Clinical Research Consortium Arizona
Phoenix, Arizona, 85004
Foothill Family Clinic South
Salt Lake City, Utah, 84121
Heartland Research Associates LLC - Augusta
Salt Lake City, Utah, 84121
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710
Children's Health Center / St. Elizabeth Medical Center
Utica, New York, 13502
Valley Stream Pediatrics
Valley Stream, New York, 11580
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, Placebo Comparator
- 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 as needed for pain
Placebo ComparatorDrug
Also called Glycerin ear drops
Glycerin ear drops (placebo) drops administered as needed for ear pain
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Placebo Comparator |
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 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.
Measured: 10, 20, 30, 45, and 60 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 differences (SPID) using FPS-R and FAECC pain scores
Measured: scores at pre-dose and 60 minutes post dose
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
Number of adverse events reported as a measure of safety and tolerability
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 posted28 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: primary outcome measure not met
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
- 178 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074007
- Sponsor's protocol ID
- AR01.007
- Status last verified
- Jan 2017
- First submitted
- 16 Jan 2014
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. 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
- NCT02074007
- Acronym / sponsor ID
- AR01.007
- 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
- TerminatedReason stopped: primary outcome measure not met
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Feb 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 5-10 drops every hour as needed for ear pain, not to exceed 10 mL of solution per ear in a 24-hour period |
| Placebo Comparator | Placebo comparator | Drug: Placebo ComparatorTopical 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. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
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 as needed for pain | Drug | AR01 - Topical Otic Solution |
| Placebo ComparatorAlso: Glycerin ear dropsGlycerin ear drops (placebo) drops administered as needed for ear pain | Drug | Placebo Comparator |
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 ear pain relief (score of 0 on pain scales)
Time frame: 10, 20, 30, 45, and 60 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 differences (SPID) using FPS-R and FAECC pain scores
Time frame: scores at pre-dose and 60 minutes post dose
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
Number of adverse events reported as a measure of safety and tolerability
Time frame: up to 30 days
Results and safety
The study was stopped early (reason given: primary outcome measure not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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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, Inc.
21 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 in people with Acute Otitis Media, run by Arbor Pharmaceuticals, Inc. at 21 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 5 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: stopped early, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 was stopped early (reason given: primary outcome measure not met). Results are not available in the source record.
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 24 Jan 2017.