PainPhase 2NCT01588535
Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media
A Phase 2 study testing benzocaine in people with Pain and Otitis Media, run by Arbor Pharmaceuticals, Inc. at 15 sites in United States.
Trial summary
This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years. Read more about this study
- Who is it for?
- Ages 2 months to 4 years
- Conditions the study is for
- Pain, Otitis Media
- What is being tested?
- benzocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2012to Aug 2012
- Phase
- Phase 2
- 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 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The patient has age in the interval 2 months ≤ age < 5.00 years, signs and symptoms of AOM, and moderate to severe pain (current episode ≤ 2 weeks duration). Moderate to severe pain is defined as a score of > or = 4 (on a scale of 0 - 10) for the FAECC scale as assessed by the primary assessor.
- The patient's parent/guardian must have read and signed the written informed consent prior to study participation.
- The patient is normally active and otherwise judged to be in good health on the basis of medical history and limited physical examination.
Who cannot join
- Patient has 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. Patients who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately. Patients with tympanostomy tubes are not allowed.
- Patient has acute or chronic otitis externa.
- Patient has chronic otitis media (current episode ≥ 2 weeks).
- Patient has seborrheic dermatitis involving the affected external ear canal or pinna.
- Patient has received any otic topical or systemic antibiotic 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).
- Patient has received any topical drying agent or over-the-counter therapy for otitis media within 36 hours prior to enrollment.
Show all 17Show fewer
- Patient has fever ≤ 102.0 F (oral or equivalent).
- Patient has known hypersensitivity to the study drug or similar compounds including any of the inactive ingredients.
- Patient is receiving medication on a chronic basis for pain (including steroidal or non steroidal anti-inflammatory drugs) and has not been on a stable dose for at least 1 month prior to entry into the study.
- Patient has clinically significant mental illness (to be determined by the Investigator).
- Patient has been exposed to any investigational agent within 30 days prior to study entry.
- Patient has been previously enrolled in this study.
- Patient or caregiver (parent/guardian) has a condition the Investigator believes will interfere with the ability to provide consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.
- Patient 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).
- Patient demonstrates clinical signs of anemia. The absolute amount of deoxygenated or abnormal hemoglobin (rather than its percentage) is required for cyanosis to be clinically evident. Patients with moderate-to-severe anemia may not appear cyanotic, even with elevated percentages of deoxygenated or abnormal hemoglobin.
- Patient has congenital (i.e., hereditary) methemoglobinemia.
- Patient has a recent history of acute gastroenteritis within 14 days prior to study entry. An association between methemoglobinemia and acute gastroenteritis in infants has been noted in several studies and may be due to acidosis from stool bicarbonate loss impairing the already immature function of the methemoglobin reductase system in these young patients.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
DiscoveReseach, Inc.
Bryan, Texas, 77082
Research Across America
Carrollton, Texas, 75010
ACCESS CLINICAL TRIALS, Inc. / Centennial Medical Center
Clarksville, Tennessee, 37203
Research Across America
Dallas, Texas, 75234
Odyssey Research
Fargo, North Dakota, 58104
Prairie Fields Family Medicine/Clinical Research Advantage
Fremont, Nebraska, 68025
Nda Baptist Clinic
Jonesboro, Arkansas, 72401
Clinical Research Center
Las Vegas, Nevada, 89104
COMMUNITY Medical Research
Miami Beach, Florida, 33141
Foothill Family Clinic
Salt Lake City, Utah, 84109
FIRSTMED
Salt Lake City, Utah, 84121
Jordon River Family Medicine
South Jordan, Utah, 84095
Dm Clinical Research
Tomball, Texas, 77375
The Iowa Clinic, Pc
West Des Moines, Iowa, 50266
About this study
Official title: Phase 2, Multicenter, Placebo-controlled, Double-masked, Randomized Study to Demonstrate Reliability and Validity of FAECC Scale (Modified FLACC) to Evaluate Relief of Pain in Subjects With Acute Otitis Media Aged >/=2 Months to <5 Years
This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.
Read the detailed description
to assess the reliability and validity of the FAECC pain scale tool in children aged 2 months to 5 years with acute otitis media given AR01 or placebo
- Conditions
- Pain, Otitis Media
- Being tested
- benzocaine, placebo
- Keywords
- pain, pain measurement, ear, middle, otitis media
- Medical subject headings
- Pain, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzocaineDrug
Also called Arbor otic, AR01
benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed
placeboDrug
placebo solution, five drops in affected ear canal each hour as needed
| Study group | Role | What they receive |
|---|---|---|
| benzocaine solution | Active comparator | ear drops Receives: Drug: benzocaine |
| Placebo | Placebo comparator | ear drops Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of primary assessor and caregiver FAECC scores using Pearson's correlation coefficient
Measured: up to 120 minutes after first dose and Day 4
Secondary outcomes (1)
reduction in pain scores from predose to each post-dose time point
Measured: up to 120 minutes after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence Downey, MD, Study director, Arbor Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588535
- Sponsor's protocol ID
- AR01.004
- Status last verified
- Mar 2015
- First submitted
- 27 Apr 2012
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Placebo-controlled, Double-masked, Randomized Study to Demonstrate Reliability and Validity of FAECC Scale (Modified FLACC) to Evaluate Relief of Pain in Subjects With Acute Otitis Media Aged >/=2 Months to <5 Years
- ClinicalTrials.gov ID
- NCT01588535
- Acronym / sponsor ID
- AR01.004
- Conditions
- Pain, Otitis Media
- Keywords
- pain, pain measurement, ear, middle, otitis media
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 May 2012 (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.
This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.
Detailed description
to assess the reliability and validity of the FAECC pain scale tool in children aged 2 months to 5 years with acute otitis media given AR01 or placebo
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benzocaine solution | Active comparator | Drug: benzocaineear drops |
| Placebo | Placebo comparator | Drug: placeboear drops |
Who may qualify
- Ages
- 2 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The patient has age in the interval 2 months ≤ age < 5.00 years, signs and symptoms of AOM, and moderate to severe pain (current episode ≤ 2 weeks duration). Moderate to severe pain is defined as a score of > or = 4 (on a scale of 0 - 10) for the FAECC scale as assessed by the primary assessor.
- The patient's parent/guardian must have read and signed the written informed consent prior to study participation.
- The patient is normally active and otherwise judged to be in good health on the basis of medical history and limited physical examination.
Key exclusion criteria (17 listed)
- Patient has 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. Patients who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately. Patients with tympanostomy tubes are not allowed.
- Patient has acute or chronic otitis externa.
- Patient has chronic otitis media (current episode ≥ 2 weeks).
- Patient has seborrheic dermatitis involving the affected external ear canal or pinna.
- Patient has received any otic topical or systemic antibiotic 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 |
|---|---|---|
| benzocaineAlso: Arbor otic, AR01benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed | Drug | benzocaine solution |
| placeboplacebo solution, five drops in affected ear canal each hour as needed | Drug | Placebo |
Primary outcome
Consistency of primary assessor and caregiver FAECC scores using Pearson's correlation coefficient
Time frame: up to 120 minutes after first dose and Day 4
1 secondary outcome
reduction in pain scores from predose to each post-dose time point
Time frame: up to 120 minutes after each dose
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 4 May 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 Downey, MD study director
Arbor Pharmaceuticals, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing benzocaine in people with Pain and Otitis Media, run by Arbor Pharmaceuticals, Inc. at 15 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 3 inclusion and 17 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 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Consistency of primary assessor and caregiver FAECC scores using Pearson's correlation coefficient (time frame: up to 120 minutes after first dose and Day 4). 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 4 May 2015.