Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
NCT ID: NCT01334957
Last Updated: 2024-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2011-06-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravenous ibuprofen
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Intravenous ibuprofen
800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Interventions
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Intravenous ibuprofen
800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients \<18 years of age
3. History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
4. Active hemorrhage or clinically significant bleeding
5. Pregnant or nursing
6. Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
7. Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions
8. Refusal to provide written authorization for use and disclosure of protected health information
18 Years
ALL
No
Sponsors
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Cumberland Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Art P Wheeler, M.D.
Role: STUDY_DIRECTOR
Cumberland Pharmaceuticals, Inc.
Locations
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UC San Diego Regional Center
La Jolla, California, United States
Neurovations (Queen of the Valley Hospital)
Napa, California, United States
University of Miami Health System
Miami, Florida, United States
Sheridan Clinical Research
Plantation, Florida, United States
RUSH Univ. Medical Center
Chicago, Illinois, United States
Univ. of Kansas Medical Center
Kansas City, Kansas, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Detroit Medical Center
Detroit, Michigan, United States
North Mississippi Sports Medicine & Orthopaedic Clinic
Tupelo, Mississippi, United States
Albany Medical Center
Albany, New York, United States
State of New York Downstate Medical Center (SUNY)
Brooklyn, New York, United States
North Shore - Long Island Jewish Health System
Manhasset, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Penn State College of Medicine
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Hendersonville Hospital/Comprehensive Pain Specialists
Hendersonville, Tennessee, United States
Parkland Memorial
Dallas, Texas, United States
Countries
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References
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Gan TJ, Candiotti K, Turan A, Buvanendran A, Philip BK, Viscusi ER, Soghomonyan S, Bergese SD; Intravenous Ibuprofen Surgical Surveillance Trial Investigational Sites. The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety. Clin Ther. 2015 Feb 1;37(2):368-75. doi: 10.1016/j.clinthera.2014.12.006. Epub 2015 Jan 13.
Other Identifiers
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CPI-CL-016
Identifier Type: -
Identifier Source: org_study_id
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