Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
Information source: Cumberland Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Fever
Intervention: Intravenous ibuprofen (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Cumberland Pharmaceuticals Official(s) and/or principal investigator(s): Art P Wheeler, M.D., Study Director, Affiliation: Cumberland Pharmaceuticals Inc.
Summary
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.
Clinical Details
Official title: A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.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. 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 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. 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. 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. 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.
Secondary outcome: To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of FeverTo Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe). To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pain: Patients with baseline VAS 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
Locations and Contacts
UCSD, San Diego, California 92103, United States
Danbury, Danbury, Connecticut 06810, United States
University of Miami - Miller School of Medicine, Miami, Florida 33136, United States
Grady, Atlanta, Georgia 30303, United States
Beth Israel Deaconnes MC, Boston, Massachusetts 02215, United States
Columbia, New York, New York 10032, United States
The University of North Carolina Hospitals, Chapel Hill, North Carolina 27599, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
The Moses H. Cone Memorial Hospital, Greensboro, North Carolina 27401-1020, United States
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States
Fairview, Cleveland, Ohio 44111, United States
The Ohio State University Medical Center, Columbus, Ohio 43210, United States
Lankenau, Wynnewood, Pennsylvania 19096, United States
Additional Information
Starting date: June 2011
Last updated: May 20, 2014
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