Healthy VolunteerPhase 2ADEPTNCT03119181
Study to Compare Active Tymbion Iontophoresis to Sham Tymbion Iontophoresis for Anesthesia of the Tympanic Membrane
A Phase 2 study testing Tymbion Lidocaine/epinephrine solution and Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution in people with Healthy Volunteer, run by Tusker Medical at 2 sites in United States.
Trial summary
A prospective, multicenter study to determine if active Tymbion iontophoresis is superior to sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane (TM). The study will use the Tula iontophoresis systems for healthy adult volunteers in an office setting, called Group A of Protocol CPR007003. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Tymbion Lidocaine/epinephrine solution and Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Apr 2017to 11 May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, 18-50 years old
- Subject is able and willing to comply with the protocol and attend all study visits
- Subject is able and willing to provide informed consent
- Subjects with air conduction hearing thresholds of 25 dB HL or better at standard frequencies up to 2000 Hz, and 45 dB or better at 4000 Hz.
- Subject is able to read and understand English
Who cannot join
- Pregnant or lactating females.
- Prior ear iontophoresis procedure
- Subjects with conductive hearing loss.
- Subjects with history of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the anesthetic drug formulation.
- Familial history of insensitivity to lidocaine or other local anesthetics of the amide type.
- Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane.
Show all 15Show fewer
- Perforated tympanic membrane.
- Subjects with known history of ear surgery or TM condition that has the potential to affect the sensitivity of the TM
- Otitis externa.
- Damaged/denuded skin in the auditory canal.
- Subjects with electrically sensitive support systems
- Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane.
- Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.
- Other conditions that would preclude performing the study procedure including ear plug incompatibility.
- Health conditions that, in the opinion of the investigator, would present undue risk to the subject, based on device/anesthetic drug product label warnings and precautions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
Camino ENT
San Jose, California, 95138
About this study
Official title: A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Tymbion Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting
A prospective, multicenter study to determine if active Tymbion iontophoresis is superior to sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane (TM). The study will use the Tula iontophoresis systems for healthy adult volunteers in an office setting, called Group A of Protocol CPR007003.
The protocol CPR007003 also includes a Group B study described in a separate Registration (NCT03197558).
Read the detailed description
The objective of the study is to determine if active Tymbion iontophoresis is superior to sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane. In addition, safety will be evaluated by review of the occurrence of adverse events.
The iontophoresis system (IPS) will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine).
Group A will consist of 40 evaluable healthy adult subjects randomized (1:1) to receive unilateral treatment (1 ear) with either active Tymbion iontophoresis or sham Tymbion iontophoresis. The sham iontophoresis procedure will be identical to the active Tymbion iontophoresis, with the exception that the iontophoresis current will not be activated (ie, the same drug solution will be applied to ears in both arms). After the completion of the iontophoresis procedure, the tympanic membrane will be tapped with a dull otologic probe to test the level of anesthesia. The subject will rate the level of pain using the Visual Analogue Scale (VAS) immediately after the tap. Investigators and subjects will be blinded to treatment assignment.
Safety assessments will be done post procedure and at follow as applicable.
- Conditions
- Healthy Volunteer
- Being tested
- Tymbion Lidocaine/epinephrine solution, Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tymbion Lidocaine/epinephrine solutionDrug
Also called 2% lidocaine HCl/ 1:100,000 epinephrine, Tymbion
The external ear canal will be filled with Tymbion drug solution
Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solutionCombination product
Also called Tula Iontophoresis System, 2% lidocaine HCl/1:100,000 epinephrine, Tymbion
The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM
| Study group | Role | What they receive |
|---|---|---|
| Active Tymbion Iontophoresis | Experimental | Unilateral treatment with active iontophoresis of Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine) using the Tusker Medical Tula Iontophoresis System. Receives: Combination Product: Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution |
| Sham Tymbion Iontophoresis | Sham comparator | The sham iontophoresis procedure will be identical to the active Tymbion iontophoresis in that Tymbion (2% lidocaine/ 1:100,000 epinephrine solution) will be placed in the external ear canal, however the iontophoresis current delivery (which facilitates penetration of drug into the tympanic membrane tissue) will not be activated. Receives: Drug: Tymbion Lidocaine/epinephrine solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-reported Visual Analog Scale (VAS) Pain Score Following Tympanic Membrane Tap for Subjects Treated With Active Tymbion Iontophoresis Compared to VAS Score for Subjects Treated With Sham Tymbion Iontophoresis.
The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity (where 0 represents "No pain" and 100 represents "The worst imaginable pain"). The subject reports their pain intensity by making a mark along the line and the line is measured to convert the subject response to numeric score (0-100 in millimeters). The data will be summarized as the difference in mean VAS scores between the two treatment groups (active Tymbion iontophoresis compared to sham Tymbion iontophoresis).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start27 Apr 2017
- Primary completion11 May 2017
- Study completion11 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tusker Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119181
- Sponsor's protocol ID
- CPR007003 - Group A
- Acronym
- ADEPT
- Status last verified
- Jan 2020
- First submitted
- 5 Apr 2017
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Tymbion Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting
- ClinicalTrials.gov ID
- NCT03119181
- Acronym / sponsor ID
- ADEPT / CPR007003 - Group A
- Conditions
- Healthy Volunteer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tusker MedicalIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter study to determine if active Tymbion iontophoresis is superior to sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane (TM). The study will use the Tula iontophoresis systems for healthy adult volunteers in an office setting, called Group A of Protocol CPR007003.
The protocol CPR007003 also includes a Group B study described in a separate Registration (NCT03197558).
Detailed description
The objective of the study is to determine if active Tymbion iontophoresis is superior to sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane. In addition, safety will be evaluated by review of the occurrence of adverse events.
The iontophoresis system (IPS) will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine).
Group A will consist of 40 evaluable healthy adult subjects randomized (1:1) to receive unilateral treatment (1 ear) with either active Tymbion iontophoresis or sham Tymbion iontophoresis. The sham iontophoresis procedure will be identical to the active Tymbion iontophoresis, with the exception that the iontophoresis current will not be activated (ie, the same drug solution will be applied to ears in both arms). After the completion of the iontophoresis procedure, the tympanic membrane will be tapped with a dull otologic probe to test the level of anesthesia. The subject will rate the level of pain using the Visual Analogue Scale (VAS) immediately after the tap. Investigators and subjects will be blinded to treatment assignment.
Safety assessments will be done post procedure and at follow as applicable.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Tymbion Iontophoresis | Experimental | Combination Product: Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solutionUnilateral treatment with active iontophoresis of Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine) using the Tusker Medical Tula Iontophoresis System. |
| Sham Tymbion Iontophoresis | Sham comparator | Drug: Tymbion Lidocaine/epinephrine solutionThe sham iontophoresis procedure will be identical to the active Tymbion iontophoresis in that Tymbion (2% lidocaine/ 1:100,000 epinephrine solution) will be placed in the external ear canal, however the iontophoresis current delivery (which facilitates penetration of drug into the tympanic membrane tissue) will not be activated. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults, 18-50 years old
- Subject is able and willing to comply with the protocol and attend all study visits
- Subject is able and willing to provide informed consent
- Subjects with air conduction hearing thresholds of 25 dB HL or better at standard frequencies up to 2000 Hz, and 45 dB or better at 4000 Hz.
- Subject is able to read and understand English
Key exclusion criteria (15 listed)
- Pregnant or lactating females.
- Prior ear iontophoresis procedure
- Subjects with conductive hearing loss.
- Subjects with history of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the anesthetic drug formulation.
- Familial history of insensitivity to lidocaine or other local anesthetics of the amide type.
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 |
|---|---|---|
| Tymbion Lidocaine/epinephrine solutionAlso: 2% lidocaine HCl/ 1:100,000 epinephrine, TymbionThe external ear canal will be filled with Tymbion drug solution | Drug | Sham Tymbion Iontophoresis |
| Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solutionAlso: Tula Iontophoresis System, 2% lidocaine HCl/1:100,000 epinephrine, TymbionThe external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM | Combination product | Active Tymbion Iontophoresis |
Primary outcome
Subject-reported Visual Analog Scale (VAS) Pain Score Following Tympanic Membrane Tap for Subjects Treated With Active Tymbion Iontophoresis Compared to VAS Score for Subjects Treated With Sham Tymbion Iontophoresis.
Time frame: Day 0
The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity (where 0 represents "No pain" and 100 represents "The worst imaginable pain"). The subject reports their pain intensity by making a mark along the line and the line is measured to convert the subject response to numeric score (0-100 in millimeters). The data will be summarized as the difference in mean VAS scores between the two treatment groups (active Tymbion iontophoresis compared to sham Tymbion iontophoresis).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
2 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 Tymbion Lidocaine/epinephrine solution and Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution in people with Healthy Volunteer, run by Tusker Medical at 2 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 15 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subject-reported Visual Analog Scale (VAS) Pain Score Following Tympanic Membrane Tap for Subjects Treated With Active Tymbion Iontophoresis Compared to VAS Score for Subjects Treated With Sham Tymbion Iontophoresis. (time frame: Day 0). 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 18 Jan 2020.