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Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow

NCT01525043 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2014-03-05

No results posted yet for this study

Summary

The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.

Conditions

  • Epicondylitis of the Elbow

Interventions

DRUG

Naproxen

Naproxen 500mg BID for the first 2 weeks

DRUG

Synera patch twice daily

1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks

DRUG

Synera patch for 12hrs/day

1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks

DRUG

Naproxen

500mg bid

DRUG

Synera

Topical appication of single patch to elbow for 12hrs/day

DRUG

Synera

Single patch applied to elbow for 4hrs/twice daily

Sponsors & Collaborators

  • International Clinical Research Institute

    lead OTHER

Principal Investigators

  • Srinivas Nalamachu, MD · International Clinical Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-02-28
Completion
2013-09-30

Countries

  • United States

Study Locations

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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 NCT01525043 on ClinicalTrials.gov