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The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesic, morphine, post surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous ibuprofen | Active Comparator |
| |
| normal saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline as placebo comparator | Other | 250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery | 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper Green Hospital / Jefferson Clinic | Birmingham | Alabama | 35233 | United States | ||
| Medical Center East / Alabama Clinical Therapeutics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19843482 | Derived | Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026. |
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A total of 319 participants were randomized into two treatment groups. Randomized participants were additionally stratified by age and weight; three participants were randomized to incorrect stratification categories. All 319 participants received at least one dose of clinical trial material.
Participants were recruited from the medical practices and/or clinics of the investigator/sub-investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Intravenous ibuprofen | Drug | 800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5) |
|
|
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Springhill Hospital / Wilmax Clinical Research, Inc. | Mobile | Alabama | 36608 | United States |
| Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc. | Mobile | Alabama | 36652-2144 | United States |
| Jackson Hospital / Drug Research and Analysis Corporation | Montgomery | Alabama | 36106 | United States |
| Baptist Medical Center South / Drug Research and Analysis Corporation | Montgomery | Alabama | 36111 | United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| Valley OB/GYN | Colton | California | 92324 | United States |
| Research Support Personnel LLC | Wichita | Kansas | 67208 | United States |
| Chandler Medical Center; Ken Muse Research | Lexington | Kentucky | 40536 | United States |
| Comprehensive Pain Specialists | Hendersonville | Tennessee | 37075 | United States |
| Health First Medical Group | Fort Worth | Texas | 76135 | United States |
| Royal Adelaide Hospital | Adelaide | 5000 | Australia |
| FG001 | 800 mg Intravenous Ibuprofen | The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia. |
| BG001 | 800 mg Intravenous Ibuprofen | The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight | Number | Kilograms |
|
| 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 | Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery | Posted | Apr 2011 | Least Squares Mean | Standard Error | milligrams | 24 Hours |
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|
14 Days
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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 | Placebo | The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia. | 6 | 153 | 149 | 153 | ||
| EG001 | 800 mg Intravenous Ibuprofen | The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia. | 12 | 166 | 150 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oxygen saturation decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Peritoneal Hemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Wound drainage | Surgical and medical procedures | MedDRA (10.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Wound Dihisence | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Rock, Ph.D. | 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 |
|---|---|
| D000077330 | Saline Solution |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Male |
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| Black or African American |
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| Hispanic |
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| Asian |
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| Other |
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| Greater than 75 kilograms |
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