Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-27 @ 4:06 PM
Study NCT ID:
NCT01901393
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2013-07-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D020911', 'term': 'Ketorolac Tromethamine'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arock@cumberlandpharma.com', 'phone': '615-255-0068', 'title': 'Amy Rock, PhD', 'organization': 'Cumberland Pharmaceutical Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'IV Ibuprofen', 'description': '800mg ibuprofen\n\nIV ibuprofen', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketorolac', 'description': '30mg ketorolac\n\nKetorolac', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of Pain Relief (Pain Intensity at Rest)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ibuprofen', 'description': '800mg ibuprofen\n\nIV ibuprofen'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': '30mg ketorolac\n\nKetorolac'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '32', 'spread': '25.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First possible time post-surgery, an expected average of 6 hours', 'description': 'Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject\'s mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).', 'unitOfMeasure': 'units on a scale (in mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on all subject who completed the VAS at Rest Immediately Following their Procedure'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Use in Post-operative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ibuprofen', 'description': '800mg ibuprofen\n\nIV ibuprofen'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': '30mg ketorolac\n\nKetorolac'}], 'classes': [{'title': 'Narcotic', 'categories': [{'measurements': [{'value': '13.7', 'spread': '17.19', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '16.50', 'groupId': 'OG001'}]}]}, {'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '188.5', 'spread': '255.06', 'groupId': 'OG000'}, {'value': '179.1', 'spread': '248.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative period until discharge, an expected average of 6 hours', 'description': 'Amount of rescue medication (in milligrams) will be measured', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Use of Rescue Med Will be Measured', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ibuprofen', 'description': '800mg ibuprofen\n\nIV ibuprofen'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': '30mg ketorolac\n\nKetorolac'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative period until discharge, an expected average of 6 hours', 'description': 'Time to first rescue medication (in hours) in the postoperative period through discharge.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ibuprofen', 'description': '800mg ibuprofen\n\nIV ibuprofen'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': '30mg ketorolac\n\nKetorolac'}], 'classes': [{'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-operative period until discharge, an expected average of 6 hours', 'description': 'Measured using 2 question, 4 point scale.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ibuprofen', 'description': '800mg ibuprofen\n\nIV ibuprofen'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': '30mg ketorolac\n\nKetorolac'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-operative period until discharge, an expected average of 6 hours', 'description': 'Number of subjects experiencing treatment-emergent serious adverse events', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy of Pain Relief (Pain Intensity With Movement)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ibuprofen', 'description': '800mg ibuprofen\n\nIV ibuprofen'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': '30mg ketorolac\n\nKetorolac'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '41', 'spread': '28.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First possible time post-surgery, an expected average of 6 hours', 'description': 'Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject\'s mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).', 'unitOfMeasure': 'units on a scale (in mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on all subject who completed the VAS with Movement Immediately Following their Procedure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Ibuprofen', 'description': '800mg ibuprofen\n\nIV ibuprofen'}, {'id': 'FG001', 'title': 'Ketorolac', 'description': '30mg ketorolac\n\nKetorolac'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Ibuprofen', 'description': '800mg ibuprofen\n\nIV ibuprofen'}, {'id': 'BG001', 'title': 'Ketorolac', 'description': '30mg ketorolac\n\nKetorolac'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '46', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '46', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The Intent-to-Treat population consisted of all subjects who were enrolled and received at least a partial dose of investigational medicinal product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-12', 'studyFirstSubmitDate': '2013-07-12', 'resultsFirstSubmitDate': '2016-01-18', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-18', 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Pain Relief (Pain Intensity at Rest)', 'timeFrame': 'First possible time post-surgery, an expected average of 6 hours', 'description': 'Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject\'s mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).'}, {'measure': 'Efficacy of Pain Relief (Pain Intensity With Movement)', 'timeFrame': 'First possible time post-surgery, an expected average of 6 hours', 'description': 'Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject\'s mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).'}], 'secondaryOutcomes': [{'measure': 'Rescue Medication Use in Post-operative Period', 'timeFrame': 'Post-operative period until discharge, an expected average of 6 hours', 'description': 'Amount of rescue medication (in milligrams) will be measured'}, {'measure': 'Time to First Use of Rescue Med Will be Measured', 'timeFrame': 'Post-operative period until discharge, an expected average of 6 hours', 'description': 'Time to first rescue medication (in hours) in the postoperative period through discharge.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Post-operative period until discharge, an expected average of 6 hours', 'description': 'Measured using 2 question, 4 point scale.'}, {'measure': 'Incidence of Serious Adverse Events', 'timeFrame': 'Post-operative period until discharge, an expected average of 6 hours', 'description': 'Number of subjects experiencing treatment-emergent serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post Operative Pain,', 'Pail relief'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for knee arthroscopy\n\nExclusion Criteria:\n\n* Inadequate IV access.\n* History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.\n* Less than 18 years of age.\n* Use of analgesics less than 8 hours prior to surgery.\n* Patients with active, clinically significant anemia.\n* History or evidence of asthma or heart failure.\n* Pregnant.\n* Recent history of chronic opioid use.\n* Concomitant use of probenecid.\n* 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.\n* Refusal to provide written authorization for use and disclosure of protected health information.'}, 'identificationModule': {'nctId': 'NCT01901393', 'briefTitle': 'Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cumberland Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Prospective, Randomized, Double-blind Study to Determine the Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery', 'orgStudyIdInfo': {'id': 'CPI-CL-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV ibuprofen', 'description': '800mg ibuprofen', 'interventionNames': ['Drug: IV ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ketorolac', 'description': '30mg ketorolac', 'interventionNames': ['Drug: Ketorolac']}], 'interventions': [{'name': 'IV ibuprofen', 'type': 'DRUG', 'otherNames': ['Caldolor'], 'armGroupLabels': ['IV ibuprofen']}, {'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['Ketorolac Tromethamine'], 'armGroupLabels': ['ketorolac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Shrock Orthopedic Research', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Sports Medicine & Orthopaedic Clinic', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Vexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Arthur P Wheeler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cumberland Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumberland Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}