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Sponsored by: |
Pacira Pharmaceuticals, Inc |
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Information provided by: | Pacira Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00485433 |
The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.
Condition | Intervention | Phase |
---|---|---|
Postoperative Pain |
Drug: SKY0402 |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair. |
Estimated Enrollment: | 100 |
Study Start Date: | June 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of any of the following medications within the times specified before surgery:
Current or historical evidence of any clinically significant condition that, in the opinion of the Investigator, may increase the risk of surgery, complicate the subject's postoperative course, or indicate an increased vulnerability to study drugs and procedures and expose the subject to an unreasonable risk as a result of participating in this clinical trial.
If during surgery the following criterion is met:
United States, California | |
Huntington Memorial Hospital | |
Pasadena, California, United States, 91105 | |
Arcadia Methodist Hospital | |
Arcadia, California, United States, 91007 | |
Saddleback Valley Outpatient Surgery | |
Laguna Hills, California, United States, 92653 | |
United States, New York | |
St. Luke's Roosevelt Hosptial Center | |
New York, New York, United States, 10025 | |
United States, Pennsylvania | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Kirby Outpatient Surgical Center | |
Houston, Texas, United States, 77054 | |
Memorial Hermann Healthcare System | |
Houston, Texas, United States, 77024 |
Responsible Party: | Pacira Pharmaceuticals, Inc. ( Marius Ardeleanu, MD / Medical Monitor ) |
Study ID Numbers: | SKY0402C207 |
Study First Received: | June 11, 2007 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00485433 |
Health Authority: | United States: Food and Drug Administration |
hernia unilateral postoperative analgesia |
Pathological Conditions, Anatomical Signs and Symptoms Postoperative Complications Hernia |
Hernia, Abdominal Pain Hernia, Inguinal Pain, Postoperative |
Pathologic Processes |