A Phase 2 interventional study of Synera (lidocaine 70mg/tetracaine 70mg) in Pain, Phlebotomy and Palliative Care, sponsored by US Oncology Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-25.
Sponsored by US Oncology Research · Phase 2, Interventional, and Treatment
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
US Oncology Research is the lead sponsor of 29 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch
Drug: Synera (lidocaine 70mg/tetracaine 70mg)
First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch
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.
Also known as: Synera
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.
Time frame: 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.
Time frame: 30 minutes after the venipuncture.
Global Assessment of Satisfaction With Venipuncture
Rates of Satisfied and very satisfied are used to be compared between two groups.
Time frame: 30 minutes after the venipuncture.
| Milestone | Synera First, Then Placebo | Placebo First, Then Synera |
|---|---|---|
| Started | 32 | 29 |
| Completed | 28 | 26 |
| Not completed | 4 | 3 |
| Withdrew: Received 1 patch | 2 | 1 |
| Withdrew: No patch received | 2 | 2 |
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 participants | Synera | Placebo |
|---|---|---|
| Percentage of Patients With No or Minor Pain (VAS<3) | 38.0 | 21.3 |
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.
| percentage of participants | Synera | Placebo |
|---|---|---|
| Percentage of Patients With No Pain (VAS=0) | 19.4 | 8.3 |
Rates of Satisfied and very satisfied are used to be compared between two groups.
| percentage of participants | Synera | Placebo |
|---|---|---|
| Global Assessment of Satisfaction With Venipuncture | 74.0 | 53.7 |
Collected over During the whole treatment period, up to 30 days following last dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Synera | — | 0/54 (0%) | 25/54 (46.3%) |
| Placebo | — | 0/54 (0%) | 18/54 (33.3%) |
| Event | Synera | Placebo |
|---|---|---|
| WELL-DEFINED ERYTHEMASkin and subcutaneous tissue disorders | 14/54 | 7/54 |
| VERY SLIGHT ERYTHEMASkin and subcutaneous tissue disorders | 11/54 | 11/54 |
ITT population
| Age, Continuous(years) | Synera First, Then Placebo | Placebo First, Then Synera | Total |
|---|---|---|---|
| Mean | 60.8 ± 11.2 | 60.3 ± 13.0 | 60.5 ± 12.0 |
| Sex: Female, Male(Participants) | Synera First, Then Placebo | Placebo First, Then Synera | Total |
|---|---|---|---|
| Female | 20 | 14 | 34 |
| Male | 12 | 15 | 27 |
| Race/Ethnicity, Customized(participants) | Synera First, Then Placebo | Placebo First, Then Synera | Total |
|---|---|---|---|
| Caucasian | 31 | 24 | 55 |
| African American | 1 | 4 | 5 |
| Indian | 0 | 1 | 1 |
| Region of Enrollment(participants) | Synera First, Then Placebo | Placebo First, Then Synera | Total |
|---|---|---|---|
| United States | 32 | 29 | 61 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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