Back to resultsStudy Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy
Primary Purpose
Patellar Tendinopathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Heated Lidocaine and Tetracaine Patch
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Tendinopathy focused on measuring Patellar tendonitis
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.)
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Sports Medicine Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heated Lidocaine and Tetracaine Patch
Arm Description
Outcomes
Primary Outcome Measures
Victorian Institute of Sport Assessment (VISA) score
VISA questionnaire, an index of severity and symptoms of patellar tendinopathy, completed by the patient (beginning and end of the study).
Secondary Outcome Measures
Pain intensity
Patient Global Assessment of Treatment Satisfaction (PGAS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01111773
Brief Title
Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy
Official Title
An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Patellar Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZARS Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinopathy
Keywords
Patellar tendonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heated Lidocaine and Tetracaine Patch
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Heated Lidocaine and Tetracaine Patch
Other Intervention Name(s)
Synera
Intervention Description
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).
Primary Outcome Measure Information:
Title
Victorian Institute of Sport Assessment (VISA) score
Description
VISA questionnaire, an index of severity and symptoms of patellar tendinopathy, completed by the patient (beginning and end of the study).
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Pain intensity
Time Frame
Two weeks
Title
Patient Global Assessment of Treatment Satisfaction (PGAS)
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Goitz, MD
Organizational Affiliation
Detroit Medical Center, Sports Medicine Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports Medicine Clinic
City
Warren
State/Province
Michigan
ZIP/Postal Code
48092
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy
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