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Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

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ClinicalTrials.gov Identifier: NCT01334944
Recruitment Status : Completed
First Posted : April 13, 2011
Results First Posted : June 23, 2014
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pain
Fever
Intervention Drug: Intravenous ibuprofen
Enrollment 150
Recruitment Details Adult patients in the hospital setting experiencing pain and/or fever.
Pre-assignment Details

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.

Arm/Group Title Fever Pain
Hide Arm/Group Description Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
Period Title: Overall Study
Started 11 139
Received Singel Dose 1 96
Received Multiple Doses 10 43
Completed 11 139
Not Completed 0 0
Arm/Group Title Intravenous Ibuprofen
Hide Arm/Group Description

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.

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

Overall Number of Baseline Participants 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Years
Greater than or equal to 18 years of age Number Analyzed 150 participants
150
[1]
Measure Description: Greater than or equal to 18 years of age
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Female
91
  60.7%
Male
59
  39.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   2.0%
Native Hawaiian or Other Pacific Islander
1
   0.7%
Black or African American
34
  22.7%
White
106
  70.7%
More than one race
0
   0.0%
Unknown or Not Reported
6
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 150 participants
150
1.Primary Outcome
Title 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.
Hide Description The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fever Pain
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
Overall Number of Participants Analyzed 11 139
Measure Type: Number
Unit of Measure: Number of Serious Adverse Events
0 0
2.Primary Outcome
Title 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.
Hide Description The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen
Arm/Group Title Fever Pain
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Overall Number of Participants Analyzed 1 96
Measure Type: Number
Unit of Measure: Number of Events
0 16
3.Primary Outcome
Title 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
Hide Description The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fever Pain
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Overall Number of Participants Analyzed 11 139
Mean (95% Confidence Interval)
Unit of Measure: Degree Fahrenheit
-0.9
(-2.7 to 0.3)
-0.1
(-3.2 to 1.6)
4.Primary Outcome
Title 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.
Hide Description The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fever Pain
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
Overall Number of Participants Analyzed 11 139
Mean (95% Confidence Interval)
Unit of Measure: Beats Per Minute
-2
(-16 to 8)
-1
(-34 to 62)
5.Primary Outcome
Title 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.
Hide Description The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fever Pain
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Overall Number of Participants Analyzed 11 139
Mean (95% Confidence Interval)
Unit of Measure: Breaths Per Minute
-1
(-5 to 2)
0
(-17 to 14)
6.Primary Outcome
Title 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.
Hide Description The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fever Pain
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Overall Number of Participants Analyzed 11 139
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
-8
(-56 to 16)
-4
(-51 to 45)
7.Primary Outcome
Title 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.
Hide Description The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fever Pain
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Overall Number of Participants Analyzed 11 139
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
-4
(-16 to 4)
-3
(-49 to 41)
8.Secondary Outcome
Title To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever
Hide Description The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fever
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
Overall Number of Participants Analyzed 11
Mean (95% Confidence Interval)
Unit of Measure: Degree Fahrenheit
-1.5
(-2.2 to -0.7)
9.Secondary Outcome
Title 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).
Hide Description 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.
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pain
Hide Arm/Group Description:
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
Overall Number of Participants Analyzed 139
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-27.1
(-33.5 to -20.7)
10.Secondary Outcome
Title To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
Hide Description The incidence of treatment-emergent serious adverse events occurring through extended dosing.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fever Pain
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
Overall Number of Participants Analyzed 10 43
Measure Type: Number
Unit of Measure: Number of Serious Adverse Events
0 1
11.Secondary Outcome
Title To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
Hide Description The incidence of treatment-emergent adverse events occurring through extended dosing.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fever Pain
Hide Arm/Group Description:
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Overall Number of Participants Analyzed 10 43
Measure Type: Number
Unit of Measure: Number of Events
0 14
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fever Pain
Hide Arm/Group Description Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
All-Cause Mortality
Fever Pain
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fever Pain
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      1/139 (0.72%)    
Vascular disorders     
Hypotension   0/11 (0.00%)  0 1/139 (0.72%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fever Pain
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      43/139 (30.94%)    
Blood and lymphatic system disorders     
Thrombocytopenia *  0/11 (0.00%)  0 1/139 (0.72%)  1
Cardiac disorders     
Tachycardia *  0/11 (0.00%)  0 2/139 (1.44%)  2
Bradycardia *  0/11 (0.00%)  0 1/139 (0.72%)  1
Ventricular Extrasystoles *  0/11 (0.00%)  0 1/139 (0.72%)  1
Eye disorders     
Blepharitis *  0/11 (0.00%)  0 1/139 (0.72%)  1
Dry Eyes *  0/11 (0.00%)  0 1/139 (0.72%)  1
Gastrointestinal disorders     
Flatulence *  0/11 (0.00%)  0 8/139 (5.76%)  8
Nausea *  0/11 (0.00%)  0 5/139 (3.60%)  6
Vomiting *  0/11 (0.00%)  0 3/139 (2.16%)  3
General disorders     
Pain *  0/11 (0.00%)  0 1/139 (0.72%)  1
Immune system disorders     
Infusion Related Reaction *  0/11 (0.00%)  0 1/139 (0.72%)  1
Injury, poisoning and procedural complications     
Infusion Site Pain *  0/11 (0.00%)  0 22/139 (15.83%)  24
Infusion Site Warmth *  0/11 (0.00%)  0 1/139 (0.72%)  1
Injection Site Pain *  0/11 (0.00%)  0 1/139 (0.72%)  1
Anaemia Postoperative *  0/11 (0.00%)  0 3/139 (2.16%)  3
Post Procedural Oedema *  0/11 (0.00%)  0 1/139 (0.72%)  1
Investigations     
Breath Sounds Abnormal *  0/11 (0.00%)  0 4/139 (2.88%)  4
Blood Creatinine Decreased *  0/11 (0.00%)  0 1/139 (0.72%)  1
Blood Pressure Systolic Increased *  0/11 (0.00%)  0 1/139 (0.72%)  1
Platelet Count Decreased *  0/11 (0.00%)  0 1/139 (0.72%)  1
Metabolism and nutrition disorders     
Hyperglycaemia *  0/11 (0.00%)  0 4/139 (2.88%)  4
Hyperchloraemia *  0/11 (0.00%)  0 1/139 (0.72%)  1
Nervous system disorders     
Headache *  0/11 (0.00%)  0 2/139 (1.44%)  2
Dizziness *  0/11 (0.00%)  0 1/139 (0.72%)  1
Hypoaesthesia *  0/11 (0.00%)  0 1/139 (0.72%)  1
Paresthesia *  0/11 (0.00%)  0 1/139 (0.72%)  1
Skin and subcutaneous tissue disorders     
Pruritus *  0/11 (0.00%)  0 3/139 (2.16%)  3
Vascular disorders     
Hypotension *  0/11 (0.00%)  0 2/139 (1.44%)  2
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Amy Rock
Organization: Cumberland Pharmaceutical Inc.
Phone: 615-255-0068
EMail: arock@cumberlandpharma.com
Layout table for additonal information
Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01334944     History of Changes
Other Study ID Numbers: CPI-CL-015
First Submitted: April 12, 2011
First Posted: April 13, 2011
Results First Submitted: April 15, 2014
Results First Posted: June 23, 2014
Last Update Posted: September 2, 2016