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Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01055444
First received: January 21, 2010
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome


Condition Intervention Phase
Shoulder Impingement Syndrome
 Drug: Heated lidocaine and tetracaine topical 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 Shoulder Impingement Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain interference with activities (general, normal work, and sleep) [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heated lidocaine/tetracaine topical patch
Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours.
 Drug: Heated lidocaine and tetracaine topical patch
Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours.
Other Name: Synera

Detailed Description:

The purpose of this single center, 2-week open-label 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 shoulder impingement syndrome. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.

  Eligibility

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

Inclusion Criteria:

  • Pain associated with shoulder impingement syndrome in a single shoulder
  • Have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder
  • Have positive Hawkins and Neers signs

Exclusion Criteria:

  • Have used any topically applied pain medication on the target treatment area within 3 days preceding 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.)
  • Have a history of and/or past diagnosis of severe hepatic disease

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055444

Locations
United States, Idaho
Injury Care Medical Center
Boise, Idaho, United States, 83713
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Principal Investigator: Richard Radnovich, DO
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT01055444     History of Changes
Other Study ID Numbers: SC-202
Study First Received: January 21, 2010
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
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 June 18, 2013