Efficacy and Safety of Synera in Osteoarthritis Pain

• Sponsor: Thomas J. Schnitzer (Other)
• Overall Status: Completed
• CT.gov ID: NCT01654302
• Collaborator: Nuvo Research Inc. (Industry)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this condition. This study examines a different topical approach, utilizing a topical anesthetic agent, to evaluate if application of such an agent would provide relief of exercise-induced knee pain in people with knee OA.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Synera; Drug: Inactive patch	Phase 1/Phase 2

Detailed Description

Subjects participated in two visits each at least 1 week apart, where they underwent two exercise interventions - a baseline exercise without treatment and a experimental exercise with intervention (Synera patch or Inactive patch). Participants rated their pain on a NRS-11 1 minute, 5 minutes, and 60 minutes after both exercises, as well as 6 hours after the experimental exercise, before bedtime, and the following morning. Subjects were randomized to receive either Synera at the first visit and the inactive patch at the second visit or the inactive patch at the first visit and Synera patch at the second visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Synera in OA Pain
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Synera lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.	Drug: Synera; 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours; Other Names: lidocaine/tetracaine
Placebo Comparator: Inactive Patch placebo patch identical in appearance and composition (namely, the heating components) to the active patch other than lacking the lidocaine and tetracaine active ingredients.	Drug: Inactive patch; placebo patch applied once for 12 hours; Other Names: placebo

Outcome Measures

Primary Outcome Measures

1. Index Knee Pain Scores on a Numeric Rating Scale (NRS) [5 minutes after stopped exercise, performed 1 hour after intervention (patch application)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Men and women, age 40 years and above

2. Meet American College of Rheumatology criteria for knee OA

3. Knee pain most days of the week for the past month

4. Knee pain > 5/10 after exercise intervention

5. Capable of undertaking exercise intervention

6. Stable cardiovascular function

7. Able to return for all clinic visits

8. Able to read and understand the informed consent document

Exclusion Criteria:

1. Use of a walker to ambulate or inability to ambulate

2. Other forms of arthritis

3. Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia

4. History of myocardial infarction

5. Blood Pressure > 140 systolic/100 diastolic

6. Scheduled for and likely to need joint replacement surgery in the next 3 months

7. Any medical condition that in the judgment of the investigator would make the participant not suitable for the study

8. Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Thomas J. Schnitzer
• Nuvo Research Inc.

Investigators

• Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas J. Schnitzer, Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT01654302
• Other Study ID Numbers: STU00061115
• First Posted: Jul 31, 2012
• Last Update Posted: May 12, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Lidocaine; Tetracaine

Study Results

Participant Flow

Arm/Group Title	Synera Then Placebo	Placebo Then Synera
Arm/Group Description	Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7).	Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
Period Title: First Intervention (Day 1)
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0
Period Title: First Intervention (Day 1)
STARTED	20	20
COMPLETED	19	19
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Synera Then Placebo	Placebo Then Synera	Total
Arm/Group Description	Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7).	Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).	Total of all reporting groups
Overall Participants	19	19	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (7.01)	60 (8.26)	58 (7.77)
Sex: Female, Male (Count of Participants)
Female	8 42.1%	15 78.9%	23 60.5%
Male	11 57.9%	4 21.1%	15 39.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	15 78.9%	14 73.7%	29 76.3%
White	4 21.1%	5 26.3%	9 23.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	19 100%	19 100%	38 100%
Baseline Index Knee Pain Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.90 (1.25)	6.26 (1.37)	6.08 (1.33)

Outcome Measures

1. Primary Outcome

Title	Index Knee Pain Scores on a Numeric Rating Scale (NRS)
Description	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.
Time Frame	5 minutes after stopped exercise, performed 1 hour after intervention (patch application)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Synera	Inactive Patch
Arm/Group Description	70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours	placebo: placebo
Measure Participants	36	37
Mean (Standard Deviation) [units on a scale]	4.167 (2.242)	4.703 (2.253)

Adverse Events

Time Frame	10 months
Arm/Group Title	Synera		Inactive Patch
Arm/Group Description	70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours		placebo: placebo
All Cause Mortality
	Synera		Inactive Patch
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Synera		Inactive Patch
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Synera		Inactive Patch
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/39 (15.4%)		2/39 (5.1%)
Skin and subcutaneous tissue disorders
Errythmia	6/39 (15.4%)	6	2/39 (5.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.