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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01744197
Other study ID # 12112
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2013
Est. completion date November 2013

Study information

Verified date September 2018
Source US Oncology Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date November 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Synera (lidocaine 70mg/tetracaine 70mg)
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.

Locations

Country Name City State
United States 19 Locations Including Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
US Oncology Research Nuvo Research Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/b — View Citation

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; — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 minutes after the venipuncture.
Primary 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. 30 minutes after the venipuncture.
Secondary Global Assessment of Satisfaction With Venipuncture Rates of Satisfied and very satisfied are used to be compared between two groups. 30 minutes after the venipuncture.
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