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The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in the hospital setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous ibuprofen | Experimental | Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous ibuprofen | Drug | 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen | 6 hours |
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen. | 6 hours |
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting | The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature) | 1 hour |
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate). | 1 hour |
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate). | 1 hour |
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever | The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration | 4 hours |
| To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Art P Wheeler, M.D. | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD | San Diego | California | 92103 | United States | ||
| Danbury |
Patients who met all the inclusion and none of the exclusion criteria during the Screening /Baseline Period were enrolled into the study.
Subjects could not have a history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or NSAIDS.
Adult patients in the hospital setting experiencing pain and/or fever.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fever | Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure). |
| 1 hour |
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure). | 1 hour |
The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100. |
| 4 hours |
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain | The incidence of treatment-emergent serious adverse events occurring through extended dosing. | 24 hours |
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain | The incidence of treatment-emergent adverse events occurring through extended dosing. | 24 hours |
| Danbury |
| Connecticut |
| 06810 |
| United States |
| University of Miami - Miller School of Medicine | Miami | Florida | 33136 | United States |
| Grady | Atlanta | Georgia | 30303 | United States |
| Beth Israel Deaconnes MC | Boston | Massachusetts | 02215 | United States |
| Columbia | New York | New York | 10032 | United States |
| The University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Moses H. Cone Memorial Hospital | Greensboro | North Carolina | 27401-1020 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Fairview | Cleveland | Ohio | 44111 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Lankenau | Wynnewood | Pennsylvania | 19096 | United States |
| Pain |
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator |
| Received Singel Dose |
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| Received Multiple Doses |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Ibuprofen | Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Intravenous ibuprofen: 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Greater than or equal to 18 years of age | Number | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen | Posted | Number | Number of Serious Adverse Events | 6 hours |
|
|
| ||||||||||||||||||||||||||||||
| Primary | To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen. | This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen | Posted | Number | Number of Events | 6 hours |
|
| ||||||||||||||||||||||||||||||
| Primary | To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting | The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature) | Posted | Mean | 95% Confidence Interval | Degree Fahrenheit | 1 hour |
|
| ||||||||||||||||||||||||||||||
| Primary | To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate). | Posted | Mean | 95% Confidence Interval | Beats Per Minute | 1 hour |
|
| ||||||||||||||||||||||||||||||
| Primary | To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate). | Posted | Mean | 95% Confidence Interval | Breaths Per Minute | 1 hour |
|
| ||||||||||||||||||||||||||||||
| Primary | To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure). | Posted | Mean | 95% Confidence Interval | mm Hg | 1 hour |
|
| ||||||||||||||||||||||||||||||
| Primary | To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. | The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure). | Posted | Mean | 95% Confidence Interval | mm Hg | 1 hour |
|
| ||||||||||||||||||||||||||||||
| Secondary | To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever | The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration | Posted | Mean | 95% Confidence Interval | Degree Fahrenheit | 4 hours |
|
| ||||||||||||||||||||||||||||||
| Secondary | To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe). | The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 hours |
|
| ||||||||||||||||||||||||||||||
| Secondary | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain | The incidence of treatment-emergent serious adverse events occurring through extended dosing. | Posted | Number | Number of Serious Adverse Events | 24 hours |
|
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| Secondary | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain | The incidence of treatment-emergent adverse events occurring through extended dosing. | Posted | Number | Number of Events | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fever | Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator | 0 | 11 | 0 | 11 | ||
| EG001 | Pain | Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator | 1 | 139 | 43 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion Site Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Infusion Site Warmth | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Injection Site Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Breath Sounds Abnormal | Investigations | Non-systematic Assessment |
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| Blood Creatinine Decreased | Investigations | Non-systematic Assessment |
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| Blood Pressure Systolic Increased | Investigations | Non-systematic Assessment |
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| Platelet Count Decreased | Investigations | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyperchloraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
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| Paresthesia | Nervous system disorders | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Ventricular Extrasystoles | Cardiac disorders | Non-systematic Assessment |
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| Anaemia Postoperative | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Blepharitis | Eye disorders | Non-systematic Assessment |
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| Dry Eyes | Eye disorders | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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| Infusion Related Reaction | Immune system disorders | Non-systematic Assessment |
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| Post Procedural Oedema | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Rock | Cumberland Pharmaceutical Inc. | 615-255-0068 | arock@cumberlandpharma.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| D005334 | Fever |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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