Trial Outcomes & Findings for Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients (NCT NCT00606489)
NCT ID: NCT00606489
Last Updated: 2011-08-11
Results Overview
Area under the curve temperature from baseline to hour 24 following initiation of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
0 to 24 hours
Results posted on
2011-08-11
Participant Flow
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.
Participant milestones
| Measure |
Placebo (250 Milliliters Normal Saline)
|
800mg Intravenous Ibuprofen
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
40
|
|
Overall Study
COMPLETED
|
21
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
Baseline characteristics by cohort
| Measure |
Placebo (250 Milliliters Normal Saline)
n=21 Participants
|
800mg Intravenous Ibuprofen
n=40 Participants
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
30 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
33 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
32 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Age, Customized
<=12 years old
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
>12 years old
|
21 participants
n=5 Participants
|
40 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
India
|
14 participants
n=5 Participants
|
31 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hoursPopulation: 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.
Area under the curve temperature from baseline to hour 24 following initiation of treatment.
Outcome measures
| Measure |
Placebo (250 Milliliters Normal Saline)
n=21 Participants
|
800mg Intravenous Ibuprofen
n=40 Participants
|
|---|---|---|
|
Temperature
|
18.29 Degree Celcius times hours (AUC-T)
Standard Error 2.2
|
12.21 Degree Celcius times hours (AUC-T)
Standard Error 1.7
|
Adverse Events
Placebo (250 Milliliters Normal Saline)
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
800mg Intravenous Ibuprofen
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (250 Milliliters Normal Saline)
n=21 participants at risk
|
800mg Intravenous Ibuprofen
n=40 participants at risk
|
|---|---|---|
|
Cardiac disorders
Cardiopulmonary arrest
|
4.8%
1/21 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Cardiac arrest
|
4.8%
1/21 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory arrest syndrome
|
9.5%
2/21 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
4.8%
1/21 • Number of events 1
|
0.00%
0/40
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Severe septic shock
|
0.00%
0/21
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Invasive wound sepsis
|
0.00%
0/21
|
2.5%
1/40 • Number of events 1
|
|
Reproductive system and breast disorders
Breathlessness
|
0.00%
0/21
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Septicemia
|
0.00%
0/21
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Placebo (250 Milliliters Normal Saline)
n=21 participants at risk
|
800mg Intravenous Ibuprofen
n=40 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
19.0%
4/21 • Number of events 4
|
15.0%
6/40 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
3/21 • Number of events 3
|
12.5%
5/40 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperchloremia
|
4.8%
1/21 • Number of events 1
|
7.5%
3/40 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.8%
1/21 • Number of events 1
|
7.5%
3/40 • Number of events 3
|
|
Vascular disorders
Hypotension
|
9.5%
2/21 • Number of events 2
|
12.5%
5/40 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
9.5%
2/21 • Number of events 2
|
7.5%
3/40 • Number of events 3
|
|
Infections and infestations
Cellulitis
|
9.5%
2/21 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Hyperthermia
|
4.8%
1/21 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Hyperpyrexia
|
9.5%
2/21 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrom
|
9.5%
2/21 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
Additional Information
Amy Rock, Doctor of Philosophy (Ph.D.)
Cumberland Pharmaceuticals
Phone: 6152550068
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place