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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01111773
First received: April 26, 2010
Last updated: March 14, 2012
Last verified: March 2012

April 26, 2010
March 14, 2012
June 2010
March 2011   (final data collection date for primary outcome measure)
Victorian Institute of Sport Assessment (VISA) score [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
VISA questionnaire, an index of severity and symptoms of patellar tendinopathy, completed by the patient (beginning and end of the study).
Same as current
Complete list of historical versions of study NCT01111773 on ClinicalTrials.gov Archive Site
  • Pain intensity [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
  • Patient Global Assessment of Treatment Satisfaction (PGAS) [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy
An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Patellar Tendinopathy

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Patellar Tendinopathy
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).
Other Name: Synera
Experimental: Heated Lidocaine and Tetracaine Patch
Intervention: Drug: Heated Lidocaine and Tetracaine Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
May 2011
March 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01111773
SC-204
No
ZARS Pharma Inc.
ZARS Pharma Inc.
Not Provided
Principal Investigator: Henry Goitz, MD Detroit Medical Center, Sports Medicine Clinic
ZARS Pharma Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP