Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caldolor | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature | Area under the curve temperature from baseline to hour 24 following initiation of treatment. | 0 to 24 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Regional Medical Center | Orlando | Florida | United States | |||
| Wake Forest University Health Sciences |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (250 Milliliters Normal Saline) | |
| FG001 | 800mg Intravenous Ibuprofen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (250 Milliliters Normal Saline) | |
| BG001 | 800mg Intravenous Ibuprofen | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Temperature | Area under the curve temperature from baseline to hour 24 following initiation of treatment. | 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. | Posted | Least Squares Mean | Standard Error | Degree Celcius times hours (AUC-T) | 0 to 24 hours |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (250 Milliliters Normal Saline) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Rock, Doctor of Philosophy (Ph.D.) | Cumberland Pharmaceuticals | 6152550068 | arock@cumberlandpharma.com |
Not provided
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo |
|
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| Naik's Hospital | Baroda | Kothi | 390001 | India |
| Lokmanya Tilak Municipal Medical College | Mumbai | Sion | 400022 | India |
| Surya Hospitals Pvt. Ltd | Pune | 411 011 | India |
Total of all reporting groups
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 3 |
| 21 |
| 15 |
| 21 |
| EG001 | 800mg Intravenous Ibuprofen | 5 | 40 | 23 | 40 |
| Cardiac arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute respiratory arrest syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Severe septic shock | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Invasive wound sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Breathlessness | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Septicemia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders |
|
| Hyperchloremia | Metabolism and nutrition disorders |
|
| Hypernatremia | Metabolism and nutrition disorders |
|
| Hypotension | Vascular disorders |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute respiratory distress syndrom | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
Not provided
Not provided