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The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator | 250 milliliters normal saline as a placebo comparator was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period. |
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| Intravenous ibuprofen | Experimental | 800 mg of intravenous ibuprofen diluted in 250 milliliters normal saline was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caldolor | Drug | 800 milligrams intravenous |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC-VAS With Movement (Post-operative Period, Hour-6-28) | 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). | Study hour-6 through hour-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Singla, MD | Lotus Clinical Research/Methodist Hospital of Southern CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmax Clinical Research Inc. | Mobile | Alabama | 336608 | United States | ||
| Teton Research, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 250 mL of normal saline. |
| FG001 | 800mg IV Ibuprofen (Caldolor) | 8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Normal Saline | Other | Placebo comparator |
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| Study hour-6 through hour-28 |
| Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28). | Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery. | Study hour-6 to hour-28 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Clinical Management Services, Inc. | Arcadia | California | 91007 | United States |
| Southeastern Center for Clinical Trials | Atlanta | Georgia | 30350 | United States |
| Research Concepts, Inc | Houston | Texas | 77054 | United States |
| Research Concepts, Inc. | Houston | Texas | 77401 | United States |
| Johannesburg General Hospital | Johannesburg | South Africa |
| Krugersdorp Private Hospital | Krugersdorp | South Africa |
| Eugene Marais Hospital | Pretoria | South Africa |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 250 mL of normal saline. |
| BG001 | 800mg IV Ibuprofen (Caldolor) | 8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | AUC-VAS With Movement (Post-operative Period, Hour-6-28) | 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). | 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 | AUC-VAS pain v. time (mm*hr) | Study hour-6 through hour-28 |
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| Secondary | Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28) | 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). | 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 | AUC-VAS pain v. time (mm*hr) | Study hour-6 through hour-28 |
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| Secondary | Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28). | Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery. | Demand of narcotic use was determined by PCA records or by chart if patient requested and not via PCA. | Posted | Apr 2011 | Mean | Standard Deviation | milligrams | Study hour-6 to hour-28 |
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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 | 250 mL of normal saline. | 3 | 86 | 74 | 86 | ||
| EG001 | 800mg IV Ibuprofen (Caldolor) | 8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose. | 8 | 99 | 90 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Post procedural pneumonia | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Acute hepatic failure | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Altered mental status | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| Acute renal failure | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Urine output decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Haemaglobin decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
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| anaemia postoperative | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Rock, Ph.D. | Cumberland Pharmaceuticals | 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 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| >= 45 years |
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| Male |
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| South Africa |
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