PainPhase 4NCT00747669
Pharmacokinetic Study of Synera™ in Neonates and Infants
A Phase 4 study testing lidocaine 70mg and tetracaine 70mg topical patch in people with Pain, run by ZARS Pharma Inc. at 1 site in United States.
Trial summary
This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Pain
- What is being tested?
- lidocaine 70mg and tetracaine 70mg topical patch
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Apr 2013
- 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 Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg.
- Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit.
- Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study.
- The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject.
Who cannot join
- Subject has known allergies or sensitivities to any component of Synera.
- Subject has clinically significant laboratory abnormalities.
- Subject has known multiple allergies that could indicate hypersensitive skin.
- Subject has known active atopic dermatitis at or near the patch application site.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Pharmacokinetic Study of Synera™ (Lidocaine 70 mg and Tetracaine 70 mg Topical Patch) to Evaluate the Systemic Exposure to Lidocaine and Tetracaine in Neonates and Infants
This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.
- Conditions
- Pain
- Being tested
- lidocaine 70mg and tetracaine 70mg topical patch
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine 70mg and tetracaine 70mg topical patchDrug
Also called Synera
One Synera Patch applied for 30 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera
Measured: 30 hours
Secondary outcomes (1)
Monitor the nature and frequency of adverse events
Measured: 30 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Why it stopped: Difficulty with enrollment
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ZARS Clinical Development, Study chair, ZARS Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747669
- Sponsor's protocol ID
- EN3274-401
- Status last verified
- Mar 2012
- First submitted
- 3 Sep 2008
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Synera™ (Lidocaine 70 mg and Tetracaine 70 mg Topical Patch) to Evaluate the Systemic Exposure to Lidocaine and Tetracaine in Neonates and Infants
- ClinicalTrials.gov ID
- NCT00747669
- Acronym / sponsor ID
- EN3274-401
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulty with enrollment
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 5 Sep 2008 (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 will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg.
- Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit.
- Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study.
- The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject.
Key exclusion criteria (4 listed)
- Subject has known allergies or sensitivities to any component of Synera.
- Subject has clinically significant laboratory abnormalities.
- Subject has known multiple allergies that could indicate hypersensitive skin.
- Subject has known active atopic dermatitis at or near the patch application site.
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 |
|---|---|---|
| lidocaine 70mg and tetracaine 70mg topical patchAlso: SyneraOne Synera Patch applied for 30 minutes. | Drug | – |
Primary outcome
Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera
Time frame: 30 hours
1 secondary outcome
Monitor the nature and frequency of adverse events
Time frame: 30 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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.
ZARS Clinical Development study chair
ZARS Pharma
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 lidocaine 70mg and tetracaine 70mg topical patch 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 4 inclusion and 4 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: paused, as of the sponsor's last update on 23 Mar 2012. 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. 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?
Results are not available in the source record.
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?
Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera (time frame: 30 hours). 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 23 Mar 2012.