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Completed

NCT Number: NCT01055444

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

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

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Key information

Conditions

Shoulder Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Injury Care Medical Center

Boise, Idaho, 83713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heated lidocaine and tetracaine topical patch

Drug

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 names: Synera

Primary outcomes

  1. Pain intensity

    Time frame: Two weeks

Secondary outcomes

  1. Pain interference with activities (general, normal work, and sleep)

    Time frame: Two weeks

Sponsors and collaborators

Lead sponsor

ZARS Pharma Inc.

Industry

Registry information

Official study title

An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 25, 2010
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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