NCT01111773

Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy

An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Patellar Tendinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: ZARS Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy.

Detailed description

The purpose of this pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population. The study will be a 2-week, open-label study conducted at a single study site in patients with pain associated with patellar tendinopathy in a single knee. During this out-patient study, patients will apply one study patch to the affected tendon twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours) and removed after 2-4 hours.

Conditions

• Patellar Tendinopathy

Interventions

Type	Name	Description
DRUG	Heated Lidocaine and Tetracaine Patch	Patients will apply one lidocaine 70 mg and tetracaine 70 mg topical patch to the affected knee twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours).

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-03-01
• Completion: 2011-05-01
• First posted: 2010-04-28
• Last updated: 2012-03-16

Locations

1 site across 1 country: United States