PainPhase 2NCT02092454
Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media
A Phase 2 study testing Benzocaine in people with Pain and Acute Otitis Media, run by Otic Therapy, LLC at 3 sites in United States.
Trial summary
To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain relief associated with acute otitis media. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Pain, Acute Otitis Media
- What is being tested?
- Benzocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2013to Mar 2014
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients ages 2 months to 12 years of age with a clinical diagnosis of AOM, and with ear pain (current episode <2 weeks duration). Baseline pain entry requires a minimum score of 4 on the FLACC or the FPS-R scale (depending on age)
- The patients must provide Institutional Review Board (IRB) approved written assent, as appropriate, which must be accompanied by an IRB approved written informed consent form (ICF) from the patient's legally acceptable representative (i.e., parent or guardian), as applicable. In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable
- Patients must be normally active and otherwise judged to be in good health on the basis of the medical history and a limited physical examination, as determined by the Investigator.
- Females of child bearing potential must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Visit 1
Who cannot join
- Patients with bilateral AOM, 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 a Valsalva maneuver
- Patients who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately.
- Patients with indwelling tympanostomy tubes or draining otitis in the affected ear(s), bullous lesions, erythema of the tympanic membrane without other evidence of AOM, and patients with an anatomic defect of the ear or nasopharynx
- Complications of treated/untreated ear disease over the past 2 weeks
- Patients with comorbidity requiring antibiotic therapy, allergy to study medication, immunologic deficiency, and major medical condition(s).
- Patients with methemoglobinemia or a history of methemoglobinemia, vertigo, inherited enzyme deficiencies, impaired cardiac or respiratory functions, epilepsy, heart diseases, hypersensitivity, pyrogenic infection at or near the skin, inflamed or infected skin, dermatitis, shock, hepatic impairment, or myasthenia gravis
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- Acute or chronic otitis externa
- Chronic otitis media (current episode ≥ 2 weeks)
- Patients who smoke are prohibited from participating in this study.
- Seborrheic dermatitis involving the affected external ear canal or pinna
- Any topical or systemic antibiotic received within the 14 days prior to study entry (topical antibiotics for acne will be allowed)
- Any topical drying agent or over-the-counter (OTC) therapy for otitis media received within 36 hours prior to enrollment
- Fever >102°F
- Known hypersensitivity to the study drug or similar compounds including any of the inactive ingredients
- Patients receiving medication on a chronic basis for pain (including steroidal or non-steroidal anti-inflammatory drugs)
- Use of ear drops or oral analgesics such as ibuprofen/acetaminophen within the 4 hours prior to study entry
- Use of sulfonamides, aminosalicylates, anti- cholinesterases, suxamethonium, antiarrhythmics, monoamine oxidase inhibitors, or tricyclic antidepressants
- Clinically significant mental illness (as determined by the Investigator)
- Exposure to any investigational agent within the 30 days prior to study entry
- Previous enrollment in this study
- Pregnant or lactating
- The child has a condition that the Investigator believes would interfere with the ability to provide assent (age appropriate) or comply with study instructions, or that might confound the interpretation of the study results, or put the child at undue risk
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Clearwater, Florida
Study site
Gresham, Oregon
Study site
Murray, Utah
About this study
Official title: Phase II, Multicenter, Double-Blind, Randomized, Vehicle-Controlled Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Ages 2 Months to 12 Years Presenting With Acute Otitis Media
To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain relief associated with acute otitis media.
- Conditions
- Pain, Acute Otitis Media
- Being tested
- Benzocaine, Placebo
- 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
topical otic solution
PlaceboDrug
topical otic solution
| Study group | Role | What they receive |
|---|---|---|
| Benzocaine | Experimental | Topical otic solution, every 1-2 hours, for up to 3 days Receives: Drug: Benzocaine |
| Placebo | Placebo comparator | Topical otic solution, every 1-2 hours, for up to 3 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Difference
Measured: 60 minutes
Secondary outcomes (7)
Pain Intensity Difference
Measured: Up to 120 minutes
Comparison of pain scores from AOM-SOS and FLACC pain measurement scales in patients 2 months to 4 years old
Measured: Up to 3 days
Comparison of pain scores from VAS and FPS-R pain measurement scales in patients 5 years to 12 years old
Measured: Up to 3 days
Physician Global Evaluation
Measured: Up to 3 days
Evaluate dosing intervals with pain measurements assessed up to 120 minutes
Measured: Up to 120 minutes
Report the onset of perceptible and meaningful pain relief using patient reports and stopwatch assessments
Patients will be given 2 stopwatches at the start of the study and instructed to stop one when they experience perceptible ('some') pain relief after the administration of the first dose (any change in pain intensity) and stop the other when they experience meaningful pain relief (a 'definite decrease in pain that makes them feel better')
Measured: Up to 120 minutes
Assess the safety and tolerability of benzocaine
Safety will be assessed by adverse event reporting on all study days. Also, vital signs (blood pressure, pulse, temperature, and respiratory rate) and physical examinations will be assessed.
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startSep 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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otic Therapy, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092454
- Sponsor's protocol ID
- OT5675
- Status last verified
- May 2015
- First submitted
- 13 Mar 2014
- Last updated
- 25 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicenter, Double-Blind, Randomized, Vehicle-Controlled Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Ages 2 Months to 12 Years Presenting With Acute Otitis Media
- ClinicalTrials.gov ID
- NCT02092454
- Acronym / sponsor ID
- OT5675
- Conditions
- Pain, Acute Otitis Media
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Otic Therapy, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Mar 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.
To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain relief associated with acute otitis media.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benzocaine | Experimental | Drug: BenzocaineTopical otic solution, every 1-2 hours, for up to 3 days |
| Placebo | Placebo comparator | Drug: PlaceboTopical otic solution, every 1-2 hours, for up to 3 days |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female patients ages 2 months to 12 years of age with a clinical diagnosis of AOM, and with ear pain (current episode <2 weeks duration). Baseline pain entry requires a minimum score of 4 on the FLACC or the FPS-R scale (depending on age)
- The patients must provide Institutional Review Board (IRB) approved written assent, as appropriate, which must be accompanied by an IRB approved written informed consent form (ICF) from the patient's legally acceptable representative (i.e., parent or guardian), as applicable. In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable
- Patients must be normally active and otherwise judged to be in good health on the basis of the medical history and a limited physical examination, as determined by the Investigator.
- Females of child bearing potential must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Visit 1
Key exclusion criteria (22 listed)
- Patients with bilateral AOM, 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 a Valsalva maneuver
- Patients who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately.
- Patients with indwelling tympanostomy tubes or draining otitis in the affected ear(s), bullous lesions, erythema of the tympanic membrane without other evidence of AOM, and patients with an anatomic defect of the ear or nasopharynx
- Complications of treated/untreated ear disease over the past 2 weeks
- Patients with comorbidity requiring antibiotic therapy, allergy to study medication, immunologic deficiency, and major medical condition(s).
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 |
|---|---|---|
| Benzocainetopical otic solution | Drug | Benzocaine |
| Placebotopical otic solution | Drug | Placebo |
Primary outcome
Summed Pain Intensity Difference
Time frame: 60 minutes
7 secondary outcomes
Pain Intensity Difference
Time frame: Up to 120 minutes
Comparison of pain scores from AOM-SOS and FLACC pain measurement scales in patients 2 months to 4 years old
Time frame: Up to 3 days
Comparison of pain scores from VAS and FPS-R pain measurement scales in patients 5 years to 12 years old
Time frame: Up to 3 days
Physician Global Evaluation
Time frame: Up to 3 days
Evaluate dosing intervals with pain measurements assessed up to 120 minutes
Time frame: Up to 120 minutes
Report the onset of perceptible and meaningful pain relief using patient reports and stopwatch assessments
Time frame: Up to 120 minutes
Assess the safety and tolerability of benzocaine
Time frame: Up to 3 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 25 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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Acute Otitis Media, run by Otic Therapy, LLC at 3 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 4 inclusion and 22 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 25 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 3 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?
Summed Pain Intensity Difference (time frame: 60 minutes). 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 25 May 2015.