Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334944
• Other study ID #: CPI-CL-015
• Status: Completed
• Phase: Phase 4
• Start date: June 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2016
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Pain

Intervention

Drug:
• Intravenous ibuprofen
400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Locations

Country	Name	City	State
United States	Grady	Atlanta	Georgia
United States	Beth Israel Deaconnes MC	Boston	Massachusetts
United States	The University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	Fairview	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Danbury	Danbury	Connecticut
United States	Duke University Medical Center	Durham	North Carolina
United States	The Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	University of Miami - Miller School of Medicine	Miami	Florida
United States	Columbia	New York	New York
United States	UCSD	San Diego	California
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	Lankenau	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever	The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration	4 hours
Secondary	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).	The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100.	4 hours
Secondary	To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain	The incidence of treatment-emergent serious adverse events occurring through extended dosing.	24 hours
Secondary	To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain	The incidence of treatment-emergent adverse events occurring through extended dosing.	24 hours