Efficacy and Safety of Synera in Osteoarthritis Pain

NCT01654302 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-05-12

Study results available
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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.

Conditions

Interventions

DRUG

Synera

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

DRUG

Inactive patch

placebo patch applied once for 12 hours

Sponsors & Collaborators

  • Nuvo Research Inc.

    collaborator INDUSTRY
  • Thomas J. Schnitzer

    lead OTHER

Principal Investigators

  • Thomas J Schnitzer, MD, PhD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-09-30
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01654302 on ClinicalTrials.gov