PainPhase 2NCT01744197

Synera Venipuncture Pain

A Phase 2 study testing Synera (lidocaine 70mg/tetracaine 70mg) in people with Pain and Phlebotomy, run by US Oncology Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Phlebotomy, Palliative Care
What is being tested?: Synera (lidocaine 70mg/tetracaine 70mg)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: Jan 2013to Nov 2013
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study.
Is 18 years of age or older.
Patients expected to undergo the first venipuncture procedure within 5 working days of enrollment.
Male or female patients
Has signed the most recent Patient Informed Consent Form
Has signed a Patient Authorization Form (HIPPA)

Who cannot join

Patients with sensitivity to lidocaine, tetracaine, or any other component of the product
Known sensitivity to any components of test materials (sulphites and adhesives)
Patients with damaged or broken skin at the designated patch site
Pregnant or breastfeeding women patients
Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products containing acetaminophen or ibuprofen with one of these agents within 4 hours of the patient's visit
Previous irradiation to the site of the patch

Trial locations and contacts

1 site in 1 country.

United States1 site

19 Locations Including
Dallas, Texas

Other trials in United States

About this study

Official title: Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures

Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended to reduce the pain associated with venipuncture and superficial dermatologic procedures by numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology patients undergoing venipuncture as part of their care, for treatment or diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS

Conditions: Pain, Phlebotomy, Palliative Care
Being tested: Synera (lidocaine 70mg/tetracaine 70mg)
Keywords: Pain control, Needle stick pain, Venipuncture pain
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 (lidocaine 70mg/tetracaine 70mg)Drug
Also called Synera
All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.

Study groups in NCT01744197
Study group	Role	What they receive
Arm 1	Experimental	First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch Receives: Drug: Synera (lidocaine 70mg/tetracaine 70mg)
Arm 2	Experimental	First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch Receives: Drug: Synera (lidocaine 70mg/tetracaine 70mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With No or Minor Pain (VAS<3)
The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS <3 is considered as patients with no or minor pain and would be compared between 2 groups.
Measured: 30 minutes after the venipuncture.
Percentage of Patients With No Pain (VAS=0)
The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups.
Measured: 30 minutes after the venipuncture.

Secondary outcomes (1)

Global Assessment of Satisfaction With Venipuncture
Rates of Satisfied and very satisfied are used to be compared between two groups.
Measured: 30 minutes after the venipuncture.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Nov 2013

First posted6 Dec 2012 (estimated)
Study startJan 2013
Primary completionFeb 2013
Study completionNov 2013

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.
Publications (2)Papers the sponsor has linked to this study.
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: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01744197
Sponsor's protocol ID: 12112
Status last verified: Sep 2018
First submitted: 4 Dec 2012
Last updated: 25 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wallace MS, Kopecky EA, Ma T, Brophy F, Campbell JC. Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (Synera) patches compared with placebo patches applied to healthy adult volunteers. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):507-13. doi: 10.1097/AAP.0b013e3181fa69b8.
PubMed 20975464
Sawyer J, Febbraro S, Masud S, Ashburn MA, Campbell JC. Heated lidocaine/tetracaine patch (Synera, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. Br J Anaesth. 2009 Feb;102(2):210-5. doi: 10.1093/bja/aen364.
PubMed 19151049

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures
ClinicalTrials.gov ID: NCT01744197
Acronym / sponsor ID: 12112
Conditions: Pain, Phlebotomy, Palliative Care
Keywords: Pain control, Needle stick pain, Venipuncture pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: US Oncology ResearchIndustry (pharma, biotech, devices)
Collaborators: Nuvo Research Inc.
Study start: Jan 2013
Primary completion: Feb 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 6 Dec 2012 (estimated)
Results: Posted 17 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: Synera (lidocaine 70mg/tetracaine 70mg)First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch
Arm 2	Experimental	Drug: Synera (lidocaine 70mg/tetracaine 70mg)First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study.
Is 18 years of age or older.
Patients expected to undergo the first venipuncture procedure within 5 working days of enrollment.
Male or female patients
Has signed the most recent Patient Informed Consent Form

Key exclusion criteria (6 listed)

Patients with sensitivity to lidocaine, tetracaine, or any other component of the product
Known sensitivity to any components of test materials (sulphites and adhesives)
Patients with damaged or broken skin at the designated patch site
Pregnant or breastfeeding women patients
Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products containing acetaminophen or ibuprofen with one of these agents within 4 hours of the patient's visit

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 (lidocaine 70mg/tetracaine 70mg)Also: SyneraAll subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.	Drug	Arm 1, Arm 2

Primary outcome

Percentage of Patients With No or Minor Pain (VAS<3)
Time frame: 30 minutes after the venipuncture.
The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS <3 is considered as patients with no or minor pain and would be compared between 2 groups.
Percentage of Patients With No Pain (VAS=0)
Time frame: 30 minutes after the venipuncture.
The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups.

1 secondary outcome

Global Assessment of Satisfaction With Venipuncture
Time frame: 30 minutes after the venipuncture.

Results and safety

Results posted to the registry on 17 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Synera First, Then Placebo	32	28
Placebo First, Then Synera	29	26

Primary outcome: Percentage of Patients With No or Minor Pain (VAS<3)

Time frame: 30 minutes after the venipuncture.. Number. Unit: percentage of participants

Measure	Synera n = 54	Placebo n = 54
Value	38.0	21.3

Population analysed: Normal completion patients.

Primary outcome: Percentage of Patients With No Pain (VAS=0)

Time frame: 30 minutes after the venipuncture.. Number. Unit: percentage of participants

Measure	Synera n = 54	Placebo n = 54
Value	19.4	8.3

Population analysed: Normal completion patients

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During the whole treatment period, up to 30 days following last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Synera	0 of 54 (0%)	25 of 54 (46.3%)	Not reported
Placebo	0 of 54 (0%)	18 of 54 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20975464Wallace MS, Kopecky EA, Ma T, Brophy F, Campbell JC. Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (Synera) patches compared with placebo patches applied to healthy adult volunteers. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):507-13. doi: 10.1097/AAP.0b013e3181fa69b8.
Results publication: PubMed 19151049Sawyer J, Febbraro S, Masud S, Ashburn MA, Campbell JC. Heated lidocaine/tetracaine patch (Synera, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. Br J Anaesth. 2009 Feb;102(2):210-5. doi: 10.1093/bja/aen364.

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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.

Melanie Matson, RN, BSN principal investigator

US Oncology Research, McKesson Specialty Health

Laura T. Guerra, RN principal investigator

US Oncology Research, McKesson Specialty Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Synera (lidocaine 70mg/tetracaine 70mg) in people with Pain and Phlebotomy, run by US Oncology Research 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 6 inclusion and 6 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 Oct 2018. 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 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 17 Feb 2016). 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?

Percentage of Patients With No or Minor Pain (VAS<3) (time frame: 30 minutes after the venipuncture.). 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?

On the ClinicalTrials.gov record for NCT01744197, which also lists 2 linked publications.

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 Oct 2018.