Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-02 @ 12:23 PM
Study NCT ID:
NCT00399568
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2006-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lawrence.hill@mallinckrodt.com', 'phone': '908-238-6370', 'title': 'Lawrence Hill', 'organization': 'Mallinckrodt Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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', 'eventGroups': [{'id': 'EG000', 'title': 'IV Acetaminophen 1g/100 mL Solution', 'description': 'Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 mL solution)', 'otherNumAtRisk': 166, 'otherNumAffected': 135, 'seriousNumAtRisk': 166, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'IV Placebo 100 mL Solution', 'description': 'Safety Population (defined as those subjects who received any portion of a dose of IV Placebo 100 mL solution)', 'otherNumAtRisk': 165, 'otherNumAffected': 145, 'seriousNumAtRisk': 165, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 88}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen 1 g/100 ml Solution', 'description': 'mITT Population IV acetaminophen 1 g/100 ml Solution'}, {'id': 'OG001', 'title': 'IV Placebo 100 ml Solution', 'description': 'mITT Population IV Placebo 100 ml solution'}], 'classes': [{'categories': [{'measurements': [{'value': '1793.3', 'spread': '481.49', 'groupId': 'OG000'}, {'value': '1845.3', 'spread': '420.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (just prior to the first dose) through 24 hours', 'description': '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.', 'unitOfMeasure': 'units on a scale (in millimeters)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.', 'anticipatedPostingDate': '2009-09'}, {'type': 'SECONDARY', 'title': 'Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen 1g/100 ml Solution', 'description': 'Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 ml solution)'}, {'id': 'OG001', 'title': 'IV Placebo 100 ml Solution', 'description': 'Safety Population(defined as those subjects who received any portion of a dose of IV Placebo 100 ml solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose through 7 day follow up', 'description': '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)', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen 1 g/100 ml Solution', 'description': 'mITT Population IV acetaminophen 1 g/100 ml Solution'}, {'id': 'OG001', 'title': 'IV Placebo 100 ml Solution', 'description': 'mITT Population IV Placebo 100 ml solution'}], 'classes': [{'categories': [{'measurements': [{'value': '3612.4', 'spread': '966.66', 'groupId': 'OG000'}, {'value': '3718.2', 'spread': '829.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (just prior to the first dose) through 48 hours', 'description': '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.', 'unitOfMeasure': 'units on a scale (in millimeters)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.', 'anticipatedPostingDate': '2009-09'}, {'type': 'SECONDARY', 'title': 'Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen 1 g/100 ml Solution', 'description': 'mITT Population IV acetaminophen 1 g/100 ml Solution'}, {'id': 'OG001', 'title': 'IV Placebo 100 ml Solution', 'description': 'mITT Population IV Placebo 100 ml solution'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 days following first dose of study medication.', 'description': 'Number of subjects who reported SAEs during the study.\n\nA serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that:\n\nResults 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', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-09'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Acetaminophen 1 g/100 mL Solution', 'description': '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.'}, {'id': 'FG001', 'title': 'IV Placebo 100 mL Solution', 'description': 'All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Gynecologists and/or anesthesiologists were selected to participate as Principal Investigators.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Acetaminophen 1 g/100 mL Solution', 'description': '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.'}, {'id': 'BG001', 'title': 'IV Placebo 100 mL Solution', 'description': 'All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'dispFirstSubmitDate': '2009-04-03', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-08', 'studyFirstSubmitDate': '2006-11-14', 'dispFirstSubmitQcDate': '2010-11-11', 'resultsFirstSubmitDate': '2009-09-25', 'studyFirstSubmitQcDate': '2006-11-14', 'dispFirstPostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-11', 'studyFirstPostDateStruct': {'date': '2006-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.', 'timeFrame': 'Baseline (just prior to the first dose) through 24 hours', 'description': '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.'}, {'measure': 'Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo', 'timeFrame': 'Baseline (just prior to the first dose) through 48 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'First dose through 7 day follow up', 'description': '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)'}, {'measure': 'Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.', 'timeFrame': '32 days following first dose of study medication.', 'description': 'Number of subjects who reported SAEs during the study.\n\nA serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that:\n\nResults 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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Gynecologic', 'IV Acetaminophen', 'Postoperative', 'Analgesic'], 'conditions': ['Postoperative Pain', 'Hysterectomy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision\n* 18-75 years of age\n* Body Mass Index (BMI) between 19-45\n* American Society of Anesthesiologists (ASA) risk class of I, II, III\n* Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery\n* Moderate to Severe pain at rest\n\nExclusion Criteria:\n\n* Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization\n* Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions\n* Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen\n* Known history of alcohol or drug abuse or misuse\n* Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal\n* Has significant medical disease(s), or conditions that may contraindicate participation in the study\n* Has participated in another clinical trial within 30 days of surgery'}, 'identificationModule': {'nctId': 'NCT00399568', 'briefTitle': 'Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery', 'orgStudyIdInfo': {'id': 'CPI-APA-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV acetaminophen 1 g/100 mL solution', 'interventionNames': ['Drug: IV Acetaminophen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IV Placebo 100 mL solution', 'interventionNames': ['Drug: IV Placebo 100 mL solution']}], 'interventions': [{'name': 'IV Acetaminophen', 'type': 'DRUG', 'otherNames': ['IV Acetaminophen (IV APAP)'], 'description': 'Intravenous acetaminophen 1 g/100 mL', 'armGroupLabels': ['IV acetaminophen 1 g/100 mL solution']}, {'name': 'IV Placebo 100 mL solution', 'type': 'DRUG', 'otherNames': ['IV Placebo (non-active product)'], 'description': 'IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)', 'armGroupLabels': ['IV Placebo 100 mL solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama (Anesthesiology)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Helen Keller Hospital', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center, Inc (JC Lincoln)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center, Inc. (Arrowhead)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Precision Trials', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': 'Arcadia Methodist Hospital', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Adventist Medical Center', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Huntington Memorial Hospital', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92672', 'city': 'San Clemente', 'state': 'California', 'country': 'United States', 'facility': 'Accurate Clinical Trials, Inc.', 'geoPoint': {'lat': 33.42697, 'lon': -117.61199}}, {'zip': '33414', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '34950', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'G and G Research, Inc.', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '32117', 'city': 'Holly Hill', 'state': 'Florida', 'country': 'United States', 'facility': 'Century Clinical Research, INC', 'geoPoint': {'lat': 29.24359, 'lon': -81.03756}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Nature Coast Clinical Research', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami School of Medicine Dept. of Anesthesiology', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Treasure Coast Obstetrics and Gynecology', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Anesthesia', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'St. Peters University Hospital, Anesthesiology', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '11208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College Dept. of Anesthesiology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook Anesthesiology Health Sciences Cente', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center (Albert Einstein College of Medicine)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Pain Managment', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Dept. of Anesthesiology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Herman/Memorial City Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Woman's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mallinckrodt', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}