Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01334944
First received: April 12, 2011
Last updated: July 9, 2013
Last verified: July 2013

April 12, 2011
July 9, 2013
June 2011
September 2012   (final data collection date for primary outcome measure)
To determine the safety of a single dose of intravenous ibuprofen administered over a 5-10 minute period for the treatment of fever or pain in the hospital setting. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01334944 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain
  • Fever
Drug: Intravenous ibuprofen
400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Other Name: Caldolor
Experimental: Intravenous ibuprofen
Intravenous 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.
Intervention: Drug: Intravenous ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
October 2012
September 2012   (final data collection date for primary outcome measure)

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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01334944
CPI-CL-015
Yes
Cumberland Pharmaceuticals
Cumberland Pharmaceuticals
Not Provided
Study Director: Art P Wheeler, M.D. Cumberland Pharmaceuticals Inc.
Cumberland Pharmaceuticals
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP