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

NCT01111773 | Completed Phase 2

• 1 other identifier: SC-204
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Tendinopathy

Keywords

Patellar tendonitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Pain intensity

  Two weeks

• Patient Global Assessment of Treatment Satisfaction (PGAS)

  Two weeks

Study Arms (1)

Heated Lidocaine and Tetracaine Patch

EXPERIMENTAL

Drug: Heated Lidocaine and Tetracaine Patch

Interventions

Heated Lidocaine and Tetracaine Patch DRUG

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).

Also known as: Synera

Heated Lidocaine and Tetracaine Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• ZARS Pharma Inc.: lead

Study Sites (1)

Sports Medicine Clinic

Warren, Michigan, 48092, United States

Location

Study Officials

• Henry Goitz, MD

  Detroit Medical Center, Sports Medicine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

US (1)