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| Name | Class |
|---|---|
| Nuvo Research Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch |
|
| Arm 2 | Experimental | First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synera (lidocaine 70mg/tetracaine 70mg) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Matson, RN, BSN | US Oncology Research, McKesson Specialty Health | Principal Investigator |
| Laura T. Guerra, RN | US Oncology Research, McKesson Specialty Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 19 Locations Including | Dallas | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20975464 | Result | 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. | |
| 19151049 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Synera First, Then Placebo | Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after). |
| FG001 | Placebo First, Then Synera | Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Synera First, Then Placebo | Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Normal completion patients. | Posted | Number | percentage of participants | 30 minutes after the venipuncture. |
|
During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Synera | Treated with Synera. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VERY SLIGHT ERYTHEMA | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melanie Matson, RN, BSN | Evergreen Hematology and Oncology | 5094642873 | mmatson@evergreen4cure.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
|
| 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. |
| Placebo First, Then Synera |
Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Normal completion patients | Posted | Number | percentage of participants | 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. | Normal completion patients | Posted | Number | percentage of participants | 30 minutes after the venipuncture. |
|
|
|
| 0 |
| 54 |
| 25 |
| 54 |
| EG001 | Placebo | Treated with Placebo | 0 | 54 | 18 | 54 |
| WELL-DEFINED ERYTHEMA | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |