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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 preemptive treatment of postoperative pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous ibuprofen | Experimental | Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous ibuprofen | Drug | 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 Over 5-10 Minutes for the Reduction of Pain. | The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen | 6 hours |
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. | 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 Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. |
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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 |
|---|---|---|---|---|---|---|
| UC San Diego Regional Center | La Jolla | California | 92037 | United States | ||
| Neurovations (Queen of the Valley Hospital) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25592331 | Derived | Gan TJ, Candiotti K, Turan A, Buvanendran A, Philip BK, Viscusi ER, Soghomonyan S, Bergese SD; Intravenous Ibuprofen Surgical Surveillance Trial Investigational Sites. The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety. Clin Ther. 2015 Feb 1;37(2):368-75. doi: 10.1016/j.clinthera.2014.12.006. Epub 2015 Jan 13. |
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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 hospitalized patients undergoing surgery
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Ibuprofen | Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen |
| 6 hours |
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | Visual Analog Scale (VAS) assessments following surgery. 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. | 6 hours |
| Napa |
| California |
| 94558 |
| United States |
| University of Miami Health System | Miami | Florida | 33136 | United States |
| Sheridan Clinical Research | Plantation | Florida | 33324 | United States |
| RUSH Univ. Medical Center | Chicago | Illinois | 60612 | United States |
| Univ. of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121-2483 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Detroit Medical Center | Detroit | Michigan | 48201 | United States |
| North Mississippi Sports Medicine & Orthopaedic Clinic | Tupelo | Mississippi | 38801 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| State of New York Downstate Medical Center (SUNY) | Brooklyn | New York | 11203 | United States |
| North Shore - Long Island Jewish Health System | Manhasset | New York | 11030 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43201 | United States |
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Hendersonville Hospital/Comprehensive Pain Specialists | Hendersonville | Tennessee | 37075 | United States |
| Parkland Memorial | Dallas | Texas | 75235 | United States |
| Received Single Dose |
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| Received Multiple Doses |
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| COMPLETED |
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| NOT COMPLETED |
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Formal sample size calculations were not performed. The intent is to enroll 300 patients to provide descriptive safety and efficacy data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Ibuprofen | Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | 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 Over 5-10 Minutes for the Reduction of Pain. | The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first 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 Reduction of Post-operative Pain. | The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen | Posted | Number | Number of Adverse Events | 6 hours |
|
| ||||||||||||||||||||||||||||
| Secondary | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. | 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 |
|
| ||||||||||||||||||||||||||||
| Secondary | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen | Posted | Number | Number of Adverse Events | 6 hours |
|
| ||||||||||||||||||||||||||||
| Secondary | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | Visual Analog Scale (VAS) assessments following surgery. 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 | 6 hours |
|
|
During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
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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 | Intravenous Ibuprofen | Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes | 8 | 300 | 49 | 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Compartment Syndrome | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Peritoneal Adhesions | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Airway Complication Of Anaesthesia | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion Site Pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Rock | Cumberland Pharmaceuticals Inc. | 615-255-0068 | arock@cumberlandpharma.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Unknown or Not Reported |
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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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