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
This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.
The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV acetaminophen 1 g/100 mL solution | Experimental |
| |
| IV Placebo 100 mL solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen | Drug | Intravenous acetaminophen 1 g/100 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo. | The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-2400 mm for 24 hours. | Baseline (just prior to the first dose) through 24 hours |
| Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo | The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-4800 mm for 48 hours. | Baseline (just prior to the first dose) through 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0) | First dose through 7 day follow up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama (Anesthesiology) | Birmingham | Alabama | 35249 | United States | ||
| Helen Keller Hospital |
Subjects were required to meet eligibility criteria prior to surgery and then again had to meet post surgical inclusion criteria.Subjects had to achieve a sufficient pain intensity score prior to entering the study.
Gynecologists and/or anesthesiologists were selected to participate as Principal Investigators.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IV Acetaminophen 1 g/100 mL Solution | All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses. |
| FG001 | IV Placebo 100 mL Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| IV Placebo 100 mL solution | Drug | IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h) |
|
|
| Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event. |
Number of subjects who reported SAEs during the study. A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that: Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event |
| 32 days following first dose of study medication. |
| Sheffield |
| Alabama |
| 35660 |
| United States |
| Arizona Research Center, Inc (JC Lincoln) | Phoenix | Arizona | 85023 | United States |
| Arizona Research Center, Inc. (Arrowhead) | Phoenix | Arizona | 85023 | United States |
| Precision Trials | Phoenix | Arizona | 85032 | United States |
| Arcadia Methodist Hospital | Arcadia | California | 91007 | United States |
| Glendale Adventist Medical Center | Glendale | California | 91206 | United States |
| Huntington Memorial Hospital | Pasadena | California | 91105 | United States |
| Accurate Clinical Trials, Inc. | San Clemente | California | 92672 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33414 | United States |
| G and G Research, Inc. | Ft. Pierce | Florida | 34950 | United States |
| Century Clinical Research, INC | Holly Hill | Florida | 32117 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| University of Miami School of Medicine Dept. of Anesthesiology | Miami | Florida | 33136 | United States |
| Treasure Coast Obstetrics and Gynecology | Vero Beach | Florida | 32960 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Cooper Anesthesia | Camden | New Jersey | 08103 | United States |
| St. Peters University Hospital, Anesthesiology | New Brunswick | New Jersey | 08901 | United States |
| Albany Medical College Dept. of Anesthesiology | Albany | New York | 11208 | United States |
| Weill Medical College | New York | New York | 10021 | United States |
| Stony Brook Anesthesiology Health Sciences Cente | Stony Brook | New York | 11794 | United States |
| Jacobi Medical Center (Albert Einstein College of Medicine) | The Bronx | New York | 10461 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Allegheny Pain Managment | Altoona | Pennsylvania | 16602 | United States |
| Thomas Jefferson University Dept. of Anesthesiology | Philadelphia | Pennsylvania | 19107 | United States |
| Memorial Herman/Memorial City Hospital | Houston | Texas | 77024 | United States |
| Texas Woman's Hospital | Houston | Texas | 77024 | United States |
All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IV Acetaminophen 1 g/100 mL Solution | All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses. |
| BG001 | IV Placebo 100 mL Solution | All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | 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 | Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo. | The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-2400 mm for 24 hours. | All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication. | Posted | Sep 2009 | Mean | Standard Deviation | units on a scale (in millimeters) | Baseline (just prior to the first dose) through 24 hours |
|
|
| |||||||||||||||||||||||||||
| Secondary | Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0) | All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of study medication. | Posted | Number | Subjects | First dose through 7 day follow up |
|
| ||||||||||||||||||||||||||||||
| Primary | Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo | The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-4800 mm for 48 hours. | All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication. | Posted | Sep 2009 | Mean | Standard Deviation | units on a scale (in millimeters) | Baseline (just prior to the first dose) through 48 hours |
|
| ||||||||||||||||||||||||||||
| Secondary | Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event. | Number of subjects who reported SAEs during the study. A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that: Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event | Posted | Sep 2009 | Number | Subjects | 32 days following first dose of study medication. |
|
|
Adverse Events were reported from the start of study medication until the follow up visit on Day 7 (+/- 2 days). Serious Adverse Events were collected for 32 days following start of study medication
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 | IV Acetaminophen 1g/100 mL Solution | Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 mL solution) | 11 | 166 | 135 | 166 | ||
| EG001 | IV Placebo 100 mL Solution | Safety Population (defined as those subjects who received any portion of a dose of IV Placebo 100 mL solution) | 14 | 165 | 145 | 165 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
Investigator may publish only after cooperative publication or 18 months after sponsor's final evaluation of study data, whichever occurs first. At least 60 days prior to submission for publication, investigator must submit manuscript to sponsor for review and comment. Sponsor has 60 day period thereafter to respond with comment. Investigator will remove confidential information at the request of sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Hill | Mallinckrodt Pharmaceuticals | 908-238-6370 | lawrence.hill@mallinckrodt.com |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
| Participants |
|
|
|