Trial Outcomes & Findings for Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients (NCT NCT00470600)
NCT ID: NCT00470600
Last Updated: 2015-08-21
Results Overview
Measurement of the patient's self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery \[variable since every surgery has a unique length of time even if it is the same procedure\] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).
COMPLETED
PHASE3
185 participants
Study hour-6 through hour-28
2015-08-21
Participant Flow
Participant milestones
| Measure |
Placebo
250 mL of normal saline.
|
800mg IV Ibuprofen (Caldolor)
8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
99
|
|
Overall Study
COMPLETED
|
86
|
99
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=86 Participants
250 mL of normal saline.
|
800mg IV Ibuprofen (Caldolor)
n=99 Participants
8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 9.9 • n=93 Participants
|
62 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
61 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
|
Age, Customized
<45years
|
6 participants
n=93 Participants
|
3 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Age, Customized
>= 45 years
|
80 participants
n=93 Participants
|
96 participants
n=4 Participants
|
176 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=93 Participants
|
70 participants
n=4 Participants
|
131 participants
n=27 Participants
|
|
Region of Enrollment
South Africa
|
25 participants
n=93 Participants
|
29 participants
n=4 Participants
|
54 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Study hour-6 through hour-28Population: 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.
Measurement of the patient's self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery \[variable since every surgery has a unique length of time even if it is the same procedure\] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).
Outcome measures
| Measure |
Placebo
n=84 Participants
250 mL of normal saline.
|
800mg IV Ibuprofen (Caldolor)
n=95 Participants
8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
|
|---|---|---|
|
AUC-VAS With Movement (Post-operative Period, Hour-6-28)
|
1326.1 AUC-VAS pain v. time (mm*hr)
Standard Error 82.0
|
1005.0 AUC-VAS pain v. time (mm*hr)
Standard Error 81.5
|
SECONDARY outcome
Timeframe: Study hour-6 through hour-28Population: 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.
Measurement of the patient's self assessment of pain at rest using a visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).
Outcome measures
| Measure |
Placebo
n=84 Participants
250 mL of normal saline.
|
800mg IV Ibuprofen (Caldolor)
n=95 Participants
8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
|
|---|---|---|
|
Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)
|
997.0 AUC-VAS pain v. time (mm*hr)
Standard Error 83.6
|
728.0 AUC-VAS pain v. time (mm*hr)
Standard Error 83.0
|
SECONDARY outcome
Timeframe: Study hour-6 to hour-28Population: Demand of narcotic use was determined by PCA records or by chart if patient requested and not via PCA.
Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.
Outcome measures
| Measure |
Placebo
n=84 Participants
250 mL of normal saline.
|
800mg IV Ibuprofen (Caldolor)
n=95 Participants
8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
|
|---|---|---|
|
Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).
|
59.5 milligrams
Standard Deviation 29.9
|
41.1 milligrams
Standard Deviation 27.3
|
Adverse Events
Placebo
800mg IV Ibuprofen (Caldolor)
Serious adverse events
| Measure |
Placebo
n=86 participants at risk
250 mL of normal saline.
|
800mg IV Ibuprofen (Caldolor)
n=99 participants at risk
8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
1/86 • Number of events 1
|
0.00%
0/99
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/99
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/86
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Post procedural pneumonia
|
0.00%
0/86
|
1.0%
1/99 • Number of events 1
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/86
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/86
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/86
|
1.0%
1/99 • Number of events 1
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/86
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/86
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/86
|
1.0%
1/99 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=86 participants at risk
250 mL of normal saline.
|
800mg IV Ibuprofen (Caldolor)
n=99 participants at risk
8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
14.0%
12/86 • Number of events 13
|
27.3%
27/99 • Number of events 28
|
|
Gastrointestinal disorders
Constipation
|
12.8%
11/86 • Number of events 11
|
20.2%
20/99 • Number of events 20
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
4/86 • Number of events 5
|
0.00%
0/99
|
|
Investigations
Body temperature increased
|
12.8%
11/86 • Number of events 11
|
8.1%
8/99 • Number of events 10
|
|
Investigations
Urine output decreased
|
9.3%
8/86 • Number of events 9
|
5.1%
5/99 • Number of events 5
|
|
Investigations
Haemaglobin decreased
|
0.00%
0/86
|
4.0%
4/99 • Number of events 4
|
|
General disorders
Pyrexia
|
17.4%
15/86 • Number of events 16
|
14.1%
14/99 • Number of events 18
|
|
General disorders
Oedema Peripheral
|
2.3%
2/86 • Number of events 2
|
3.0%
3/99 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
19.8%
17/86 • Number of events 22
|
10.1%
10/99 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.5%
3/86 • Number of events 3
|
1.0%
1/99 • Number of events 1
|
|
Vascular disorders
Hypotension
|
7.0%
6/86 • Number of events 6
|
8.1%
8/99 • Number of events 9
|
|
Vascular disorders
Hypertension
|
3.5%
3/86 • Number of events 3
|
3.0%
3/99 • Number of events 4
|
|
Vascular disorders
Deep vein thrombosis
|
3.5%
3/86 • Number of events 3
|
1.0%
1/99 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
11.6%
10/86 • Number of events 10
|
10.1%
10/99 • Number of events 10
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
2/86 • Number of events 2
|
9.1%
9/99 • Number of events 10
|
|
Renal and urinary disorders
Dysuria
|
5.8%
5/86 • Number of events 6
|
2.0%
2/99 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.2%
1/86 • Number of events 1
|
3.0%
3/99 • Number of events 3
|
|
Nervous system disorders
Headache
|
5.8%
5/86 • Number of events 7
|
3.0%
3/99 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
3.5%
3/86 • Number of events 4
|
4.0%
4/99 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
2.3%
2/86 • Number of events 2
|
7.1%
7/99 • Number of events 7
|
|
Psychiatric disorders
Agitation
|
1.2%
1/86 • Number of events 1
|
3.0%
3/99 • Number of events 3
|
|
Cardiac disorders
Tachycardia
|
3.5%
3/86 • Number of events 3
|
4.0%
4/99 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.5%
3/86 • Number of events 3
|
5.1%
5/99 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.7%
4/86 • Number of events 4
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
anaemia postoperative
|
0.00%
0/86
|
3.0%
3/99 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
34.9%
30/86 • Number of events 37
|
44.4%
44/99 • Number of events 47
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place