Trial Outcomes & Findings for Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients (NCT NCT01002573)
NCT ID: NCT01002573
Last Updated: 2016-11-07
Results Overview
Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
118 participants
Primary outcome timeframe
0 to 2 hours post-dose
Results posted on
2016-11-07
Participant Flow
Participant milestones
| Measure |
Ibuprofen
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
|
Overall Study
COMPLETED
|
47
|
53
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
| Measure |
Ibuprofen
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Overall Study
Subject did not receive at least 1 dose
|
11
|
7
|
Baseline Characteristics
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Ibuprofen
n=47 Participants
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=53 Participants
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
6 months to 2 years
|
6 participants
n=5 Participants
|
14 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Age, Customized
2 years to 6 years
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Age, Customized
6 years to 16 years
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 2 hours post-dosePopulation: Some participants data was not included in the analysis due to having too few/insufficient data
Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)
Outcome measures
| Measure |
Ibuprofen
n=46 Participants
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=50 Participants
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Fever Reduction
|
-1.5 degree Celsius*Time
Standard Deviation 1.11
|
-0.9 degree Celsius*Time
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: 30 minutes following treatmentPopulation: Some participants data was not included in the analysis due to having too few/insufficient data
Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.
Outcome measures
| Measure |
Ibuprofen
n=45 Participants
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=53 Participants
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Change From Baseline in Temperature After the First 30 Minutes of Treatment
|
-0.5 Celsius
Standard Deviation 0.50
|
-0.3 Celsius
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: 60 minutes following treatmentPopulation: Some participants data was not included in the analysis due to having too few/insufficient data
Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.
Outcome measures
| Measure |
Ibuprofen
n=45 Participants
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=53 Participants
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Change From Baseline in Temperature After the First 60 Minutes of Treatment
|
-0.9 Celsius
Standard Deviation 0.69
|
-0.5 Celsius
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: 4 hours following treatmentPopulation: Some participants data was not included in the analysis due to having too few/insufficient data
Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.
Outcome measures
| Measure |
Ibuprofen
n=43 Participants
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=37 Participants
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Change in Temperature
|
-1.5 Celsius
Standard Deviation 0.92
|
-0.9 Celsius
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 0 to 4 hours post-dosePopulation: Some participants data was not included in the analysis due to having too few/insufficient data
Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4)
Outcome measures
| Measure |
Ibuprofen
n=44 Participants
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=42 Participants
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Change From Baseline in Temperature After the First Four Hours of Treatment
|
-4.4 degree Celsius*Time
Standard Deviation 2.59
|
-2.6 degree Celsius*Time
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: 4 Hour post treatmentTme to afebrility (temperature less than 100.4 ºF \[38 ºC\]) in patients receiving intravenous ibuprofen and APAP.
Outcome measures
| Measure |
Ibuprofen
n=47 Participants
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=53 Participants
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Time to Afebrility (in Hours)
|
2.2 Hours
Standard Deviation 0.47
|
3.3 Hours
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 4 Hours Post-DosePopulation: Some participants data was not included in the analysis due to having too few/insufficient data
Number of Afebrile and Febrile Subject at 4 Hours Following Treatment
Outcome measures
| Measure |
Ibuprofen
n=46 Participants
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=51 Participants
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose
Afebrile Subjects at 4 hours
|
43 participants
|
40 participants
|
|
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose
Febrile at 4 Hours
|
3 participants
|
11 participants
|
Adverse Events
Ibuprofen
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Acetaminophen
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibuprofen
n=47 participants at risk
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=53 participants at risk
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
2.1%
1/47 • Number of events 1
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/47
|
1.9%
1/53 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.1%
1/47 • Number of events 1
|
0.00%
0/53
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
2.1%
1/47 • Number of events 1
|
0.00%
0/53
|
|
Infections and infestations
Abdoimnal Abscess
|
0.00%
0/47
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Transaminases Increased
|
2.1%
1/47 • Number of events 1
|
0.00%
0/53
|
Other adverse events
| Measure |
Ibuprofen
n=47 participants at risk
Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg
|
Acetaminophen
n=53 participants at risk
Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
6.4%
3/47 • Number of events 4
|
5.7%
3/53 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/47 • Number of events 1
|
7.5%
4/53 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
6.4%
3/47 • Number of events 3
|
3.8%
2/53 • Number of events 2
|
|
Investigations
Aspartate Aminotransferase Increased
|
4.3%
2/47 • Number of events 2
|
3.8%
2/53 • Number of events 2
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
2.1%
1/47 • Number of events 1
|
5.7%
3/53 • Number of events 3
|
|
Investigations
Alanine Aminotransferase Increased
|
4.3%
2/47 • Number of events 2
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Blood Albumin Decreased
|
4.3%
2/47 • Number of events 2
|
0.00%
0/53
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/47
|
3.8%
2/53 • Number of events 2
|
|
Investigations
Oxygen Saturation Decreased
|
4.3%
2/47 • Number of events 2
|
0.00%
0/53
|
|
General disorders
Infusion Site Pain
|
10.6%
5/47 • Number of events 7
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hypokaelmia
|
2.1%
1/47 • Number of events 1
|
3.8%
2/53 • Number of events 2
|
|
Nervous system disorders
Headache
|
6.4%
3/47 • Number of events 3
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/47 • Number of events 1
|
3.8%
2/53 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
2/47 • Number of events 2
|
0.00%
0/53
|
Additional Information
Senior Manager, Clinical Operations
Cumberland Pharmaceuticals Inc.
Phone: 615-255-0068
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place