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Sponsored by: |
Pacira Pharmaceuticals, Inc |
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Information provided by: | Pacira Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00529126 |
Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.
Condition | Intervention | Phase |
---|---|---|
Postoperative Pain |
Drug: SKY0402 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, 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 Subject Undergoing Hemorrhoidectomy |
Estimated Enrollment: | 100 |
Study Start Date: | September 2007 |
Study Completion Date: | July 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: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of any of the following medications within the times specified before surgery:
Significant medical conditions or laboratory results that, in the opinion of the Investigator, 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, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, severe renal impairment, advanced diabetes, comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.
In addition, the subject will be ineligible to receive study drug if he or she meets the following criteria during surgery:
United States, California | |
Accurate Clinical Trials, Inc. | |
San Clemente, California, United States, 92673 | |
United States, Florida | |
University of Miami/Jackson Memorial | |
Miami, Florida, United States, 33136 | |
United States, Texas | |
The Women's Hospital of Texas | |
Houston, Texas, United States, 77054 | |
United States, Washington | |
Multicare Health Systems Laboratories | |
Tacoma, Washington, United States, 98405 | |
Georgia | |
JSC K. Eristavi National Center of Experimental and Clinical Surgery | |
Tbilisi, Georgia, 0159 | |
Socieety with limited responsibility Proctology Center | |
Tbilisi, Georgia, 0160 | |
JSC Imereti Regional Clinical Hospital of the Name A. Dzotsenidze | |
Kutaisi, Georgia, 4600 |
Responsible Party: | Pacira Pharmaceuticals, Inc. ( Marius Ardeleanu, MD / Medical Monitor ) |
Study ID Numbers: | SKY0402C209 |
Study First Received: | September 12, 2007 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00529126 |
Health Authority: | United States: Food and Drug Administration; Georgia: formerly USSR |
pain Postoperative analgesia |
Signs and Symptoms Postoperative Complications Pain Pain, Postoperative |
Pathologic Processes |