Clinical trial NCT01334944: Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
Official title: A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Fever
Keywords: Pain
Fever
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 hours
measure: 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.
timeFrame: 6 hours
measure: 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
timeFrame: 1 hour
measure: 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.
timeFrame: 1 hour
measure: 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.
timeFrame: 1 hour
measure: 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.
timeFrame: 1 hour
measure: 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.
timeFrame: 1 hour
Secondary outcomes:
measure: To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever
timeFrame: 4 hours
measure: 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).
timeFrame: 4 hours
measure: To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
timeFrame: 24 hours
measure: To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD
state: California
city: Danbury
country: United States
facility: Danbury
state: Connecticut
city: Miami
country: United States
facility: University of Miami - Miller School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Grady
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconnes MC
state: Massachusetts
city: New York
country: United States
facility: Columbia
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina Hospitals
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: The Moses H. Cone Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Fairview
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Wynnewood
country: United States
facility: Lankenau
state: Pennsylvania
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art P Wheeler, M.D.
role: STUDY_DIRECTOR
References: