PainPhase 4NCT00891163
Evaluate the Depth and Duration of Anesthesia
A Phase 4 study testing Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine) in people with Pain, run by ZARS Pharma Inc. at 1 site in United States.
Trial summary
The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations)… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Apr 2007
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Had no known significant diseases
- Normal 12-lead electrocardiogram
- Willing to refrain from using any local topical preparations
Who cannot join
- Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours
- Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components
- Had an active dermatological disease of any origin that may have interfered with their ability to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Medical Center, Thornton Hospital
San Diego, California, 92037-7651
About this study
Official title: A Randomized, Double-Blind, Two-Period, Crossover Study to Evaluate the Depth and Duration of Anesthesia of Synera™ Patches Compared to Placebo Patches Applied to Healthy Adult Volunteers
The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.
- Conditions
- Pain
- Being tested
- Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine), Placebo Patch
- Keywords
- Topical anesthesia, Analgesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)Drug
30 minute applicable on antecubital fossa
Placebo PatchDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Synera | Experimental | Not described Receives: Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory and pain depth measurements
Measured: 0, 30, 60, 90, 120 and 150 minutes
Dermal and thermal sensory testing evaluations
Measured: 0, 30, 60, 90, 120 and 150 minutes
Secondary outcomes (2)
Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch
Measured: Throughout the study
Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startDec 2006
- Primary completionApr 2007
- Study completionApr 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891163
- Sponsor's protocol ID
- EN3274-101
- Status last verified
- Apr 2009
- First submitted
- 29 Apr 2009
- Last updated
- 1 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Two-Period, Crossover Study to Evaluate the Depth and Duration of Anesthesia of Synera™ Patches Compared to Placebo Patches Applied to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00891163
- Acronym / sponsor ID
- EN3274-101
- Conditions
- Pain
- Keywords
- Topical anesthesia, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- Dec 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 1 May 2009 (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.
The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synera | Experimental | Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine) |
| Placebo | Placebo comparator | Drug: Placebo Patch |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Had no known significant diseases
- Normal 12-lead electrocardiogram
- Willing to refrain from using any local topical preparations
Key exclusion criteria (3 listed)
- Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours
- Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components
- Had an active dermatological disease of any origin that may have interfered with their ability to participate
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 |
|---|---|---|
| Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)30 minute applicable on antecubital fossa | Drug | Synera |
| Placebo Patchplacebo | Drug | Placebo |
Primary outcome
Sensory and pain depth measurements
Time frame: 0, 30, 60, 90, 120 and 150 minutes
Dermal and thermal sensory testing evaluations
Time frame: 0, 30, 60, 90, 120 and 150 minutes
2 secondary outcomes
Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch
Time frame: Throughout the study
Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)
Time frame: Throughout the study
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 1 May 2009.
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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 4 study testing Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine) in people with Pain, run by ZARS Pharma Inc. 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 3 inclusion and 3 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 1 May 2009. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Sensory and pain depth measurements (time frame: 0, 30, 60, 90, 120 and 150 minutes). The study lists 2 primary outcomes in all. 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 1 May 2009.