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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR EXPAREL

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505(b)(2) Clinical Trials for Exparel

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01349140 EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks Completed Pacira Pharmaceuticals, Inc Phase 1/Phase 2 2012-02-01 EXPARELâ„¢, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to determine the effect on thigh muscle strength and skin sensitivity of various doses of EXPAREL when placed next to the nerve that goes to the thigh.
New Formulation NCT01349140 EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks Completed University of California, San Diego Phase 1/Phase 2 2012-02-01 EXPARELâ„¢, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to determine the effect on thigh muscle strength and skin sensitivity of various doses of EXPAREL when placed next to the nerve that goes to the thigh.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Exparel

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00485433 Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair Completed Pacira Pharmaceuticals, Inc Phase 2 2007-06-01 The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.
NCT00485693 Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty Completed Pacira Pharmaceuticals, Inc Phase 2 2007-06-01 Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty
NCT00529126 Phase 2 Dose-Ranging Study of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy Completed Pacira Pharmaceuticals, Inc Phase 2 2007-09-01 Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.
NCT00813111 Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation Terminated Pacira Pharmaceuticals, Inc Phase 3 2008-11-01 The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
NCT00890682 Study of Postoperative Analgesia in Bunionectomy Completed Pacira Pharmaceuticals, Inc Phase 3 2009-04-01 After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.
NCT00890721 Study of Pain Control in Hemorrhoidectomy Completed Pacira Pharmaceuticals, Inc Phase 3 2009-05-01 Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.
NCT01349140 EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks Completed Pacira Pharmaceuticals, Inc Phase 1/Phase 2 2012-02-01 EXPARELâ„¢, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to determine the effect on thigh muscle strength and skin sensitivity of various doses of EXPAREL when placed next to the nerve that goes to the thigh.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Exparel

Condition Name

Condition Name for Exparel
Intervention Trials
Pain, Postoperative 25
Pain 25
Postoperative Pain 19
Osteoarthritis 6
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Condition MeSH

Condition MeSH for Exparel
Intervention Trials
Pain, Postoperative 62
Osteoarthritis 16
Osteoarthritis, Knee 9
Fractures, Bone 8
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Clinical Trial Locations for Exparel

Trials by Country

Trials by Country for Exparel
Location Trials
United States 226
Belgium 3
Denmark 3
Poland 1
Georgia 1
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Trials by US State

Trials by US State for Exparel
Location Trials
Ohio 24
New York 22
Texas 21
Florida 16
California 14
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Clinical Trial Progress for Exparel

Clinical Trial Phase

Clinical Trial Phase for Exparel
Clinical Trial Phase Trials
Phase 4 111
Phase 3 17
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Exparel
Clinical Trial Phase Trials
Recruiting 61
Not yet recruiting 43
Completed 41
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Clinical Trial Sponsors for Exparel

Sponsor Name

Sponsor Name for Exparel
Sponsor Trials
Pacira Pharmaceuticals, Inc 53
Mayo Clinic 7
Registrat-Mapi 6
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Sponsor Type

Sponsor Type for Exparel
Sponsor Trials
Other 164
Industry 55
U.S. Fed 7
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