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

Phase 2

Completed

• Conditions: Patellar Tendinopathy
• Interventions: Drug: Heated Lidocaine and Tetracaine Patch

• Registration Number: NCT01111773
• Lead Sponsor: ZARS Pharma Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-28
• Study Start: 2010-06
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Status Verified: 2012-03
• Disposition First Submitted: 2012-03-14
• Disposition First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Disposition First Posted: 2012-03-16
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heated Lidocaine and Tetracaine Patch	Heated Lidocaine and Tetracaine Patch	-

Primary Outcome Measures

Name	Time	Method
Victorian Institute of Sport Assessment (VISA) score	Two weeks	VISA questionnaire, an index of severity and symptoms of patellar tendinopathy, completed by the patient (beginning and end of the study).

Secondary Outcome Measures

Name	Time	Method
Patient Global Assessment of Treatment Satisfaction (PGAS)	Two weeks
Pain intensity	Two weeks

Trial Locations

Locations (1)

Sports Medicine Clinic; 🇺🇸 Warren, Michigan, United States