Efficacy and Safety of Synera in Osteoarthritis Pain

This study is not yet open for participant recruitment.

Verified April 2013 by Northwestern University

Sponsor:

Collaborator:

Nuvo Research Inc.

Information provided by (Responsible Party):

Thomas J. Schnitzer, Northwestern University

ClinicalTrials.gov Identifier:

NCT01654302

First received: July 11, 2012

Last updated: April 3, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2012

Last Updated Date

April 3, 2013

Start Date ^ICMJE

September 2013

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

knee pain scores on a numeric rating scale (NRS) [ Time Frame: during the 5 minutes after exercise ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01654302 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

composite arthritis score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 1 and 5 minutes, 12 hours and 1 day after exercise ] [ Designated as safety issue: No ]
Quality of life on the Short Form 12 (SF12) [ Time Frame: 1 and 5 minutes, 12 hours and 1 day after exercise ] [ Designated as safety issue: No ]
pain quality on the Pain Quality Assessment Scale (PQAS) [ Time Frame: 1 and 5 minutes, 12 hours and 1 day after exercise ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Synera in Osteoarthritis Pain

Official Title ^ICMJE

Efficacy and Safety of Synera in OA Pain

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Knee Osteoarthritis

Intervention ^ICMJE

Drug: 70 mg lidocaine/ 70 mg tetracaine topical patch
70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours

Other Name: Synera
Drug: placebo
placebo

Study Arm (s)

Active Comparator: Synera
Intervention: Drug: 70 mg lidocaine/ 70 mg tetracaine topical patch
Placebo Comparator: Inactive Patch
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Men and women, age 40 years and above
Meet American College of Rheumatology criteria for knee OA
Knee pain most days of the week for the past month
Knee pain > 5/10 after exercise intervention
Capable of undertaking exercise intervention
Stable cardiovascular function
Able to return for all clinic visits
Able to read and understand the informed consent document

Exclusion Criteria:

Use of a walker to ambulate or inability to ambulate
Other forms of arthritis
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
History of myocardial infarction
Blood Pressure > 140 systolic/100 diastolic
Scheduled for and likely to need joint replacement surgery in the next 3 months
Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Renita Yeasted

312-503-2820

renita.yeasted@northwestern.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01654302

Other Study ID Numbers ^ICMJE

STU00061115

Has Data Monitoring Committee

Responsible Party

Thomas J. Schnitzer, Northwestern University

Study Sponsor ^ICMJE

Thomas J. Schnitzer

Collaborators ^ICMJE

Nuvo Research Inc.

Investigators ^ICMJE

Principal Investigator:

Thomas J Schnitzer, MD, PhD

Northwestern University

Information Provided By

Northwestern University

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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