Trial Outcomes & Findings for Synera Venipuncture Pain (NCT NCT01744197)
NCT ID: NCT01744197
Last Updated: 2018-10-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
30 minutes after the venipuncture.
Results posted on
2018-10-25
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Received 1 patch
|
2
|
1
|
|
Overall Study
No patch received
|
2
|
2
|
Baseline Characteristics
Synera Venipuncture Pain
Baseline characteristics by cohort
| Measure |
Synera First, Then Placebo
n=32 Participants
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).
|
Placebo First, Then Synera
n=29 Participants
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).
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
31 participants
n=5 Participants
|
24 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after the venipuncture.Population: Normal completion patients.
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.
Outcome measures
| Measure |
Synera
n=54 Participants
Treated with Synera.
|
Placebo
n=54 Participants
Treated with Placebo.
|
|---|---|---|
|
Percentage of Patients With No or Minor Pain (VAS<3)
|
38.0 percentage of participants
|
21.3 percentage of participants
|
PRIMARY outcome
Timeframe: 30 minutes after the venipuncture.Population: Normal completion patients
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.
Outcome measures
| Measure |
Synera
n=54 Participants
Treated with Synera.
|
Placebo
n=54 Participants
Treated with Placebo.
|
|---|---|---|
|
Percentage of Patients With No Pain (VAS=0)
|
19.4 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: 30 minutes after the venipuncture.Population: Normal completion patients
Rates of Satisfied and very satisfied are used to be compared between two groups.
Outcome measures
| Measure |
Synera
n=54 Participants
Treated with Synera.
|
Placebo
n=54 Participants
Treated with Placebo.
|
|---|---|---|
|
Global Assessment of Satisfaction With Venipuncture
|
74.0 percentage of participants
|
53.7 percentage of participants
|
Adverse Events
Synera
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Synera
n=54 participants at risk
Treated with Synera.
|
Placebo
n=54 participants at risk
Treated with Placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
VERY SLIGHT ERYTHEMA
|
20.4%
11/54 • Number of events 11 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
20.4%
11/54 • Number of events 11 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Skin and subcutaneous tissue disorders
WELL-DEFINED ERYTHEMA
|
25.9%
14/54 • Number of events 14 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
13.0%
7/54 • Number of events 7 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
Additional Information
Melanie Matson, RN, BSN
Evergreen Hematology and Oncology
Phone: 5094642873
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place