Trial Outcomes & Findings for Efficacy and Safety of Synera in Osteoarthritis Pain (NCT NCT01654302)
NCT ID: NCT01654302
Last Updated: 2015-05-12
Results Overview
Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
5 minutes after stopped exercise, performed 1 hour after intervention (patch application)
Results posted on
2015-05-12
Participant Flow
Participant milestones
| Measure |
Synera Then Placebo
Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7).
|
Placebo Then Synera
Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
|
|---|---|---|
|
First Intervention (Day 1)
STARTED
|
20
|
20
|
|
First Intervention (Day 1)
COMPLETED
|
20
|
20
|
|
First Intervention (Day 1)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Day 7)
STARTED
|
20
|
20
|
|
Second Intervention (Day 7)
COMPLETED
|
19
|
19
|
|
Second Intervention (Day 7)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Synera Then Placebo
Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7).
|
Placebo Then Synera
Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
|
|---|---|---|
|
Second Intervention (Day 7)
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Synera in Osteoarthritis Pain
Baseline characteristics by cohort
| Measure |
Synera Then Placebo
n=19 Participants
Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7).
|
Placebo Then Synera
n=19 Participants
Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 7.01 • n=5 Participants
|
60 years
STANDARD_DEVIATION 8.26 • n=7 Participants
|
58 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Baseline Index Knee Pain Scores
|
5.90 units on a scale
STANDARD_DEVIATION 1.25 • n=5 Participants
|
6.26 units on a scale
STANDARD_DEVIATION 1.37 • n=7 Participants
|
6.08 units on a scale
STANDARD_DEVIATION 1.33 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after stopped exercise, performed 1 hour after intervention (patch application)Population: Of the 40 subjects 2 were lost to follow-up, one from each group, making a total of 38 participants included in the analysis. Unfortunately, NRS data at 5 minutes post-exercise is missing for 2 subjects in the Synera treatment group and 1 subject in the Placebo group due to technical errors. The data was captured but we were unable to retrieve it.
Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.
Outcome measures
| Measure |
Synera
n=36 Participants
70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
|
Inactive Patch
n=37 Participants
placebo: placebo
|
|---|---|---|
|
Index Knee Pain Scores on a Numeric Rating Scale (NRS)
|
4.167 units on a scale
Standard Deviation 2.242
|
4.703 units on a scale
Standard Deviation 2.253
|
Adverse Events
Synera
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Inactive Patch
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Synera
n=39 participants at risk
70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
|
Inactive Patch
n=39 participants at risk
placebo: placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Errythmia
|
15.4%
6/39 • Number of events 6 • 10 months
|
5.1%
2/39 • Number of events 2 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place