Overview

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

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ZARS Pharma Inc.
Treatments:
Lidocaine
Tetracaine
Criteria
Inclusion Criteria:

- be at least 18 years of age

- have pain associated with patellar tendinopathy in a single knee (minimum 2-week
duration)

- have tenderness at the proximal insertion of the patellar tendon in the affected knee

Exclusion Criteria:

- have any history of surgery in the target knee

- have used any topically applied pain medication on the target treatment area within 3
days preceding the Screening/Baseline Visit

- have had any injected steroids in the target knee within 3 months of the
Screening/Baseline Visit

- have used any injected pain medication within 14 days preceding the Screening/Baseline
Visit

- are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)

Other protocol-defined inclusion/exclusion criteria may apply.