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

January 21, 2010
March 14, 2012
March 2010
August 2010   (final data collection date for primary outcome measure)
Pain intensity [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01055444 on ClinicalTrials.gov Archive Site
Pain interference with activities (general, normal work, and sleep) [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome
An Open-Label Pilot Study Evaluating Synera® in the 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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Shoulder Impingement Syndrome
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
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.
Intervention: Drug: Heated lidocaine and tetracaine topical patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2010
August 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01055444
SC-202
No
ZARS Pharma Inc.
ZARS Pharma Inc.
Not Provided
Principal Investigator: Richard Radnovich, DO
ZARS Pharma Inc.
March 2012

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