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

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ClinicalTrials.gov Identifier: NCT01055444
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Shoulder Impingement Syndrome Drug: Heated lidocaine and tetracaine topical patch Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome
Study Start Date : March 2010
Primary Completion Date : August 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Pain intensity [ Time Frame: Two weeks ]

Secondary Outcome Measures :
  1. Pain interference with activities (general, normal work, and sleep) [ Time Frame: Two weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT01055444     History of Changes
Other Study ID Numbers: SC-202
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Syndrome
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action