Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients

• Sponsor: Cumberland Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00606489
• Collaborator: (none)
• Enrollment: 61
• Locations: 5
• Arms: 2
• Duration (Months): 18
• Patients Per Site: 12.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.

Condition or Disease	Intervention/Treatment	Phase
Burns	Drug: Caldolor; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Fever and Pain in Burn Patients
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: Placebo; Placebo
Experimental: 2	Drug: Caldolor; 800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours

Outcome Measures

Primary Outcome Measures

1. Temperature [0 to 24 hours]

   Area under the curve temperature from baseline to hour 24 following initiation of treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with second and/or third degree thermal burns covering more than 10 percent total body surface area (including face) with anticipated hospital stay greater than 72 hours.

2. Adequate intravenous access

3. Have fever, documented by temperature greater than or equal to 38.0 degree celsius (100.4 degree fahrenheit)

Exclusion Criteria:

1. Patients with electric burns

2. Use of acetaminophen, non-steriodal anti-inflammatory agents (NSAIDs) or other fever reducing medications within 4 hours prior to dosing

3. Patients taking warfarin or lithium

4. Active, clinically significant asthma

5. History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), or COX-2 inhibitors

6. Pregnant or nursing

7. History of severe head trauma that required current hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or central nervous system mass lesion

8. Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction

9. Have gastrointestional bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)

10. Have a platelet count less than 20,000 mm^3

11. Be on dialysis

12. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (clopidogrel, prophylaxis with enoxaparin or subcutaneous heparin is acceptable)

13. 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 (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.)

14. Refusal to provide written authorization for use and disclosure of protected health information (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.)

15. Have received another investigational drug within the past 30 days

16. Be otherwise unsuitable for the study in the opinion of the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orlando Regional Medical Center	Orlando	Florida	United States
2	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
3	Naik's Hospital	Baroda	Kothi	India	390001
4	Lokmanya Tilak Municipal Medical College	Mumbai	Sion	India	400022
5	Surya Hospitals Pvt. Ltd	Pune		India	411 011

Sponsors and Collaborators

• Cumberland Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00606489
• Other Study ID Numbers: CPI-CL-010
• First Posted: Feb 4, 2008
• Last Update Posted: Aug 11, 2011
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Burns; Ibuprofen

Study Results

Participant Flow

Recruitment Details	Participants were patients admitted to the study centers who had second and third degree thermal burns covering more than 10% total body surface area, including the face.

Arm/Group Title	Placebo (250 Milliliters Normal Saline)	800mg Intravenous Ibuprofen
Arm/Group Description
Period Title: Overall Study
STARTED	21	40
COMPLETED	21	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo (250 Milliliters Normal Saline)	800mg Intravenous Ibuprofen	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	21	40	61
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30 (11.9)	33 (10.8)	32 (11.2)
Age, Customized (participants) [Number]
<=12 years old	0 0%	0 0%	0 0%
>12 years old	21 100%	40 100%	61 100%
Sex: Female, Male (Count of Participants)
Female	11 52.4%	25 62.5%	36 59%
Male	10 47.6%	15 37.5%	25 41%
Region of Enrollment (participants) [Number]
United States	7 33.3%	9 22.5%	16 26.2%
India	14 66.7%	31 77.5%	45 73.8%

Outcome Measures

1. Primary Outcome

Title	Temperature
Description	Area under the curve temperature from baseline to hour 24 following initiation of treatment.
Time Frame	0 to 24 hours

Outcome Measure Data

Analysis Population Description

Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.

Arm/Group Title	Placebo (250 Milliliters Normal Saline)	800mg Intravenous Ibuprofen
Arm/Group Description
Measure Participants	21	40
Least Squares Mean (Standard Error) [Degree Celcius times hours (AUC-T)]	18.29 (2.2)	12.21 (1.7)

Adverse Events

Arm/Group Title	Placebo (250 Milliliters Normal Saline)		800mg Intravenous Ibuprofen
Arm/Group Description
All Cause Mortality
	Placebo (250 Milliliters Normal Saline)		800mg Intravenous Ibuprofen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo (250 Milliliters Normal Saline)		800mg Intravenous Ibuprofen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/21 (14.3%)		5/40 (12.5%)
Cardiac disorders
Cardiopulmonary arrest	1/21 (4.8%)	1	0/40 (0%)	0
Cardiac arrest	1/21 (4.8%)	1	0/40 (0%)	0
Infections and infestations
Severe septic shock	0/21 (0%)	0	1/40 (2.5%)	1
Invasive wound sepsis	0/21 (0%)	0	1/40 (2.5%)	1
Septicemia	0/21 (0%)	0	1/40 (2.5%)	1
Reproductive system and breast disorders
Breathlessness	0/21 (0%)	0	1/40 (2.5%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory arrest syndrome	2/21 (9.5%)	2	1/40 (2.5%)	1
Tachypnoea	1/21 (4.8%)	1	0/40 (0%)	0
Vascular disorders
Hypotension	1/21 (4.8%)	1	0/40 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo (250 Milliliters Normal Saline)		800mg Intravenous Ibuprofen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/21 (71.4%)		23/40 (57.5%)
Blood and lymphatic system disorders
Leukocytosis	4/21 (19%)	4	6/40 (15%)	6
Anemia	3/21 (14.3%)	3	5/40 (12.5%)	5
Gastrointestinal disorders
Constipation	2/21 (9.5%)	2	1/40 (2.5%)	1
General disorders
Hyperthermia	1/21 (4.8%)	1	2/40 (5%)	2
Hyperpyrexia	2/21 (9.5%)	2	1/40 (2.5%)	1
Infections and infestations
Cellulitis	2/21 (9.5%)	2	1/40 (2.5%)	1
Metabolism and nutrition disorders
Hyperchloremia	1/21 (4.8%)	1	3/40 (7.5%)	3
Hypernatremia	1/21 (4.8%)	1	3/40 (7.5%)	3
Respiratory, thoracic and mediastinal disorders
Tachypnoea	2/21 (9.5%)	2	3/40 (7.5%)	3
Acute respiratory distress syndrom	2/21 (9.5%)	2	1/40 (2.5%)	1
Vascular disorders
Hypotension	2/21 (9.5%)	2	5/40 (12.5%)	5

Limitations/Caveats

[Not Specified]

More Information

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.