PainPhase 3NCT03116737
Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
A Phase 3 study testing Benzocaine Otic Solution in people with Pain and Acute Otitis Media, run by Lachlan Pharma Holdings at 1 site in United States.
Trial summary
The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Pain, Acute Otitis Media
- What is being tested?
- Benzocaine Otic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 21 Jul 2017
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients ages 5 to 12 years of age with a clinical diagnosis of unilateral AOM, and with ear pain (current episode <2 weeks duration). Baseline pain entry requires a minimum score of 4 on the FPS-R.
- Patients/guardians 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 physically 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 childbearing potential must also have a negative urine human chorionic gonadotropin (hCG) pregnancy test on the Study Day, Visit 1.
Who cannot join
- Patients unable or refusing to independently and consistently complete the FPS-R pain measurements.
- 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 other than qualifying AOM over the past 2 weeks.
- Patients with comorbidity requiring antibiotic therapy, allergy to study medication, immunologic deficiency, and major medical condition(s).
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- Patients presenting with methemoglobinemia or a history of methemoglobinemia, vertigo, inherited enzyme deficiencies (including G6PD), impaired cardiac or respiratory functions, epilepsy, heart diseases, hypersensitivity to benzocaine or any other related drug product, inflamed or infected skin, dermatitis, previous medication related shock episode, hepatic impairment, or myasthenia gravis.
- Acute or chronic otitis externa.
- Chronic otitis media (current episode ≥ 2 weeks).
- Patients who smoke.
- Dermatitis involving the affected external ear canal or pinna.
- Any topical or systemic antibiotic received within the 14 days prior to study entry.
- Patients administered vaccinations a week prior to or on any of the Study Day Visits.
- Any ear drops, topical drying agent or over-the-counter (OTC) therapy for any ear related issue received within 36 hours prior to enrollment.
- Fever >102°F or at any elevated level considered necessary by the study investigator.
- 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).
- Oral analgesics such as ibuprofen/acetaminophen within 6 hours prior to study entry.
- Use of drug products with potential interactions including sulfonamides, aminosalicylates, anti-cholinesterases, suxamethonium, antiarrhythmics, monoamine oxidase inhibitors, or tricyclic antidepressants within 14 days.
- Eating, drinking, chewing of gum, or use of mints/lozenges during the first hour after initial study dose.
- Children that use pacifiers and/or are still breastfed.
- Exposure to any investigational agent within the 30 days prior to study entry.
- Previous enrollment in this study.
- Pregnant or lactating.
- Clinically significant mental or emotional illnesses (by history or as determined by the on-site investigator).
- The child has a condition or demonstrates a behavior that the Investigator or site personnel believe would interfere with the ability to provide assent (age appropriate) or comply with study instructions/tasks, or that might confound the interpretation of the study results, or put the child or others at risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Parallel-Designed Evaluation to Assess Safety and Efficacy of Topical Benzocaine for Treatment of Pain Associated With Acute Otitis Media in Children Ages 5 to 12 Years
The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.
- Conditions
- Pain, Acute Otitis Media
- Being tested
- Benzocaine Otic Solution, Placebo
- Keywords
- AOM
- 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.
Benzocaine Otic SolutionDrug
PlaceboDrug
Also called Topical otic solution
| Study group | Role | What they receive |
|---|---|---|
| Benzocaine Otic Solution | Experimental | Not described Receives: Drug: Benzocaine Otic Solution |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)
Measured: 60 minutes
Secondary outcomes (7)
Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)
Measured: 120 minutes
Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)
Measured: Up to 3 days
Dosing Intervals
Measured: Up to 3 days
Use of Rescue Medications
Measured: Up to 3 days
Assess the Safety and Tolerability of Benzocaine Based on Reported Adverse Events
Safety will be assessed by adverse event reporting on all study days. Fisher's exact test will be used to compare adverse event rates between treatment groups for the following categories: 1) all adverse events; 2) treatment related adverse events; 3) severe adverse events; 4) serious adverse events; 5) discontinuation due to adverse event.
Measured: Up to 3 days
Assess the Safety and Tolerability of Benzocaine Based on Physical Examinations
Physical examinations will be assessed. For each body system of the physical examination, the shift from normal/abnormal will be presented by treatment group as the number and percentage of children.
Measured: Up to 3 days
Assess the Safety and Tolerability of Benzocaine Based on Vital Signs
Vital signs (blood pressure, pulse, temperature, and respiratory rate) will be assessed. Descriptive statistics will be presented for the vital signs measurements collected, as well as the vital sign changes from Day 1 to Day 3 by treatment group.
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 posted17 Apr 2017
- Study start3 Jan 2017
- Primary completion21 Jul 2017
- Study completion21 Jul 2017
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lachlan Pharma Holdings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116737
- Sponsor's protocol ID
- LP7700
- Status last verified
- Oct 2017
- First submitted
- 3 Apr 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Parallel-Designed Evaluation to Assess Safety and Efficacy of Topical Benzocaine for Treatment of Pain Associated With Acute Otitis Media in Children Ages 5 to 12 Years
- ClinicalTrials.gov ID
- NCT03116737
- Acronym / sponsor ID
- LP7700
- Conditions
- Pain, Acute Otitis Media
- Keywords
- AOM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Lachlan Pharma HoldingsIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 17 Apr 2017 (actual)
- 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.
The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.
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 |
|---|---|---|
| Benzocaine Otic Solution | Experimental | Drug: Benzocaine Otic Solution |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female patients ages 5 to 12 years of age with a clinical diagnosis of unilateral AOM, and with ear pain (current episode <2 weeks duration). Baseline pain entry requires a minimum score of 4 on the FPS-R.
- Patients/guardians 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 physically 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 childbearing potential must also have a negative urine human chorionic gonadotropin (hCG) pregnancy test on the Study Day, Visit 1.
Key exclusion criteria (26 listed)
- Patients unable or refusing to independently and consistently complete the FPS-R pain measurements.
- 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 other than qualifying AOM over the past 2 weeks.
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 |
|---|---|---|
| Benzocaine Otic Solution | Drug | Benzocaine Otic Solution |
| PlaceboAlso: Topical otic solution | Drug | Placebo |
Primary outcome
Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)
Time frame: 60 minutes
7 secondary outcomes
Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)
Time frame: 120 minutes
Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)
Time frame: Up to 3 days
Dosing Intervals
Time frame: Up to 3 days
Use of Rescue Medications
Time frame: Up to 3 days
Assess the Safety and Tolerability of Benzocaine Based on Reported Adverse Events
Time frame: Up to 3 days
Assess the Safety and Tolerability of Benzocaine Based on Physical Examinations
Time frame: Up to 3 days
Assess the Safety and Tolerability of Benzocaine Based on Vital Signs
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 13 Oct 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benzocaine Otic Solution in people with Pain and Acute Otitis Media, run by Lachlan Pharma Holdings at 1 site 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 26 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) (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 13 Oct 2017.