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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 intensity

Patient 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

Page last updated: August 23, 2015

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