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
  Purpose

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.


Condition Intervention Phase
Patellar Tendinopathy
Drug: Heated Lidocaine and Tetracaine Patch
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Patellar Tendinopathy

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heated Lidocaine and Tetracaine Patch 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111773

Locations
United States, Michigan
Sports Medicine Clinic
Warren, Michigan, United States, 48092
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Principal Investigator: Henry Goitz, MD Detroit Medical Center, Sports Medicine Clinic
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT01111773     History of Changes
Other Study ID Numbers: SC-204
Study First Received: April 26, 2010
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Patellar tendonitis

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014