Patellar Tendinopathy
Conditions
Keywords
Patellar tendonitis
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.
Interventions
DRUGHeated 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).
Sponsors
ZARS Pharma Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pain intensity | Two weeks |
| Patient Global Assessment of Treatment Satisfaction (PGAS) | Two weeks |
Countries
United States
Outcome results
None listed