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

Patellar Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111773
• Other study ID #: SC-204
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2010
• Last updated: March 14, 2012
• Start date: June 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patellar Tendinopathy
• Tendinopathy

Intervention

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).

Locations

Country	Name	City	State
United States	Sports Medicine Clinic	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Two weeks	Yes
Secondary	Pain intensity		Two weeks	Yes
Secondary	Patient Global Assessment of Treatment Satisfaction (PGAS)		Two weeks	Yes