Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.
1 other identifier
interventional
150
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Jun 2011
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
June 23, 2014
CompletedJuly 5, 2023
July 1, 2016
1.3 years
April 12, 2011
April 15, 2014
June 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
6 hours
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.
The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.
6 hours
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
The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)
1 hour
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.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).
1 hour
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.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).
1 hour
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.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).
1 hour
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.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).
1 hour
Secondary Outcomes (4)
To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever
4 hours
To 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).
4 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
24 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
24 hours
Study Arms (1)
Intravenous ibuprofen
EXPERIMENTALIntravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Interventions
400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Eligibility Criteria
You may qualify if:
- Pain: Patients with baseline Visual Analog Scale assessment \>3, -and/or- Fever: Patients with temperature \>101°F.
You may not qualify if:
- Patients with inadequate IV access
- Patients \<18 years of age
- History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
- Active hemorrhage or clinically significant bleeding
- Pregnant or nursing
- Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
- 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
- Refusal to provide written authorization for use and disclosure of protected health information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Amy Rock
- Organization
- Cumberland Pharmaceutical Inc.
Study Officials
- STUDY DIRECTOR
Art P Wheeler, M.D.
Cumberland Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2011
First Posted
April 13, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
July 5, 2023
Results First Posted
June 23, 2014
Record last verified: 2016-07