NCT01525043

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

Randomized, Parallel-Group, Open Label, Dose Finding Study to Evaluate the Efficacy of Synera Patch Compared to Naproxen Sodium for the Treatment of Lateral and Medial Epicondylitis of the Elbow

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: International Clinical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

The objective of this single center is to evaluate the safety and efficacy of Synera ® in lateral and medial epicondylitis . This is an open-label, comaparative study study where the subjects will be randomized to one of the following groups: 1. Synera patch ®: A single patch applied for 4 hours twice daily approximatey 12 hrs apart to the medial or lateral side of the index elbow 2. Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow 3. Naproxen Sodium: 500mg bid

Conditions

• Epicondylitis of the Elbow

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-02-01
• Completion: 2013-09-01
• First posted: 2012-02-02
• Last updated: 2014-03-05

Locations

1 site across 1 country: United States