Surgical 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:
NCT01334957
First received: April 12, 2011
Last updated: May 20, 2014
Last verified: May 2014
Results First Received: April 15, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pain
Intervention: Drug: Intravenous ibuprofen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult hospitalized patients undergoing surgery

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Patients who met all the inclusion and none of the exclusion criteria during the Screening /Baseline Period were enrolled into the study.

Subjects could not have a history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or NSAIDS.


Reporting Groups
  Description
Intravenous Ibuprofen

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes


Participant Flow:   Overall Study
    Intravenous Ibuprofen  
STARTED     300 [1]
COMPLETED     300 [1]
NOT COMPLETED     0  
[1] 252 participants received a single dose and 48 participants received multiple doses



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Formal sample size calculations were not performed. The intent is to enroll 300 patients to provide descriptive safety and efficacy data.

Reporting Groups
  Description
Intravenous Ibuprofen

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes


Baseline Measures
    Intravenous Ibuprofen  
Number of Participants  
[units: participants]
  300  
Age, Customized [1]
[units: years]
 
Greater than or equal to 18 years of age     300  
Gender  
[units: participants]
 
Female     189  
Male     111  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     29  
Not Hispanic or Latino     271  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     5  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     60  
White     229  
More than one race     0  
Unknown or Not Reported     5  
Region of Enrollment  
[units: participants]
 
United States     300  
[1] Greater than or equal to 18 years of age



  Outcome Measures
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1.  Primary:   To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.   [ Time Frame: 6 hours ]

2.  Primary:   To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.   [ Time Frame: 6 hours ]

3.  Secondary:   To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.   [ Time Frame: 6 hours ]

4.  Secondary:   To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.   [ Time Frame: 6 hours ]

5.  Secondary:   To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.   [ Time Frame: 6 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Amy Rock
Organization: Cumberland Pharmaceuticals Inc.
phone: 615-255-0068
e-mail: arock@cumberlandpharma.com


No publications provided


Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01334957     History of Changes
Other Study ID Numbers: CPI-CL-016
Study First Received: April 12, 2011
Results First Received: April 15, 2014
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration