A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.

CPI-CL-015

The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in the hospital setting.

2011-06-01

2012-09-01

2012-10-01

Completed

Early phase I

150

Inclusion Criteria: * Pain: Patients with baseline Visual Analog Scale assessment \>3, -and/or- Fever: Patients with temperature \>101°F. Exclusion Criteria: 1. Patients with inadequate IV access 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}

2023-07-05