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

NCT ID: NCT01111773

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-05-31

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.

Conditions

Patellar Tendinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heated Lidocaine and Tetracaine Patch

Group Type: EXPERIMENTAL

Heated Lidocaine and Tetracaine Patch

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Synera

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZARS Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Goitz, MD

Role: PRINCIPAL_INVESTIGATOR

Detroit Medical Center, Sports Medicine Clinic

Locations

Sports Medicine Clinic

Warren, Michigan, United States

Countries

United States

Other Identifiers

SC-204

Identifier Type: -

Identifier Source: org_study_id