Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy
Information source: ZARS Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patellar Tendinopathy
Intervention: Heated Lidocaine and Tetracaine Patch (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: ZARS Pharma Inc. Official(s) and/or principal investigator(s): Henry Goitz, MD, Principal Investigator, Affiliation: Detroit Medical Center, Sports Medicine Clinic
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.
Clinical Details
Official title: An Open-label Pilot Study Evaluating SyneraŽ in the Treatment of Patients With Patellar Tendinopathy
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Victorian Institute of Sport Assessment (VISA) score
Secondary outcome: Pain intensityPatient Global Assessment of Treatment Satisfaction (PGAS)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sports Medicine Clinic, Warren, Michigan 48092, United States
Additional Information
Starting date: June 2010
Last updated: March 14, 2012
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