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

March 14, 2012 updated by: ZARS Pharma Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Warren, Michigan, United States, 48092
        • Sports Medicine Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Heated Lidocaine and Tetracaine Patch
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).
Other Names:
  • Synera

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity
Time Frame: Two weeks
Two weeks
Patient Global Assessment of Treatment Satisfaction (PGAS)
Time Frame: Two weeks
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZARS Pharma Inc.

Investigators

  • Principal Investigator: Henry Goitz, MD, Detroit Medical Center, Sports Medicine Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (ESTIMATE)

April 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC-204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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