Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT00225732
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2005-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arock@cumberlandpharma.com', 'phone': '615-255-0068', 'title': 'Amy Rock, Ph.D.', 'organization': 'Cumberland Pharmaceuticals Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '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.', 'otherNumAtRisk': 153, 'otherNumAffected': 149, 'seriousNumAtRisk': 153, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': '800 mg Intravenous Ibuprofen', 'description': '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.', 'otherNumAtRisk': 166, 'otherNumAffected': 150, 'seriousNumAtRisk': 166, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 132, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 137, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 41, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 47, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 51, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 50, 'numAffected': 32}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Peritoneal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Abdominal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Peritoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Wound drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Wound Dihisence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '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.'}, {'id': 'OG001', 'title': '800 mg Intravenous Ibuprofen', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 Hours', 'description': 'Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-04'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '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.'}, {'id': 'FG001', 'title': '800 mg Intravenous Ibuprofen', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the medical practices and/or clinics of the investigator/sub-investigators.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '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.'}, {'id': 'BG001', 'title': '800 mg Intravenous Ibuprofen', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than or equal to 45 years', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}, {'title': '45 to 70 years of age', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'title': 'Less than or equal to 75 kilograms', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'Greater than 75 kilograms', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Kilograms'}]}}, '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': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2005-09-22', 'resultsFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2005-09-22', 'lastUpdatePostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-10', 'studyFirstPostDateStruct': {'date': '2005-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery', 'timeFrame': '24 Hours', 'description': 'Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '19843482', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Scheduled for elective abdominal hysterectomy surgery with anticipated need for post-operative I.V. morphine analgesia with anticipated use of ≥ 24 hours.\n2. Adequate IV access\n3. Anticipated hospital stay ≥ 24 hours\n\nExclusion Criteria:\n\n1. Be unable to make a reliable self-report of pain intensity to pain relief\n2. Less than 18 years of age\n3. Greater than 70 years of age\n4. Use of NSAIDs within 12 hours prior to dosing\n5. Use of analgesics, muscle relaxants and sedatives less than 24 hours prior to CTM administration with the following exceptions: paracetamol (acetaminophen) can be administered until 6 hours prior to surgery; tramadol can be administered until midnight the evening prior to surgery; muscle relaxants working at the neuromuscular junction used for intubation and/or anesthesia administration for the surgical procedure prior to CTM administration; and sedatives (i.e., midazolam) used as a co-induction agent for the surgical procedure prior to CTM administration\n6. Patients taking warfarin, lithium, combination of ACE-inhibitors and furosemide\n7. Patients with anemia (active clinically significant) and/or a history or evidence of asthma or heart failure\n8. History of allergy or hypersensitivity to any component of Caldolor, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors\n9. Pregnant or nursing\n10. History of severe head trauma that required current hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm or CNS mass lesion\n11. Weigh less than 30kg\n12. Have a history of congenital bleeding diathesis (eg hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction\n13. Have GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)\n14. Have a platelet count less than 30,000mm3 determined within the 28 days prior to surgery\n15. Pre-existing dependence on narcotics or known tolerance to opioids\n16. Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \\[IRB\\]), and agree to abide by the study restrictions and to return for the required assessments\n17. Refusal to provide written authorization for use and disclosure of protected health information\n18. Be on dialysis, have oliguria or calculated creatinine clearance of less than 60 mL/min (calculated using the Cockcroft and Gault formula) determined within the 28 days prior to surgery\n19. Inability to achieve hemostasis or inability to close surgical incision, prior to Operating Room discharge\n20. Operative procedure includes organ transplant\n21. Pre or intra-operative procedure utilized for the prevention of pre- or post-operative pain (i.e. epidural or nerve blocks)\n22. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (Prophylaxis with subcutaneous heparin is acceptable)\n23. Have received another investigational drug within the past 30 days\n24. Be otherwise unsuitable for the study in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT00225732', 'briefTitle': 'Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cumberland Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in the Post-Operative Adult Patients', 'orgStudyIdInfo': {'id': 'CPI-CL-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intravenous ibuprofen', 'interventionNames': ['Drug: Intravenous ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'interventionNames': ['Other: Normal saline as placebo comparator']}], 'interventions': [{'name': 'Normal saline as placebo comparator', 'type': 'OTHER', 'otherNames': ['NS'], 'description': '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)', 'armGroupLabels': ['normal saline']}, {'name': 'Intravenous ibuprofen', 'type': 'DRUG', 'otherNames': ['Caldolor'], 'description': '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.\n\nThose patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)', 'armGroupLabels': ['intravenous ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cooper Green Hospital / Jefferson Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Center East / Alabama Clinical Therapeutics', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Springhill Hospital / Wilmax Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36652-2144', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36106', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Jackson Hospital / Drug Research and Analysis Corporation', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '36111', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Baptist Medical Center South / Drug Research and Analysis Corporation', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92324', 'city': 'Colton', 'state': 'California', 'country': 'United States', 'facility': 'Valley OB/GYN', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Support Personnel LLC', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Chandler Medical Center; Ken Muse Research', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '37075', 'city': 'Hendersonville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Comprehensive Pain Specialists', 'geoPoint': {'lat': 36.30477, 'lon': -86.62}}, {'zip': '76135', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Health First Medical Group', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '5000', 'city': 'Adelaide', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumberland Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}