Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome
|Carpal Tunnel Syndrome||Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch||Phase 2|
|Study Design:||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 Carpal Tunnel Syndrome|
- Pain intensity [ Time Frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal ]
- Pain interference with activities (general, normal work, sleep) [ Time Frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal ]
|Study Start Date:||September 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Synera topical patch
Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch
Patients will apply a single Synera patch to the target wrist for 2 hours twice a day (ie, morning and evening applications) for 14 days.
ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions.
The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991068
|United States, Kansas|
|International Clinical Research Institute|
|Overland Park, Kansas, United States, 66211|
|Principal Investigator:||Srinivas Nalamachu, MD||International Clinical Research Institute|