Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-07 @ 10:23 AM
Study NCT ID:
NCT00840203
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2009-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesalamine 4 gm/60 mL Rectal Enema
Sponsor:
Organization:
Raw JSON
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period'}], 'classes': [{'categories': [{'measurements': [{'value': '1451.739', 'spread': '718.488', 'groupId': 'OG000'}, {'value': '1500.290', 'spread': '778.674', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciPctValue': '90', 'paramValue': '97.6', 'ciLowerLimit': '88.6', 'ciUpperLimit': '107', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on Cmax', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}, {'type': 'PRIMARY', 'title': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period'}, {'id': 'OG001', 'title': 'Rowasa®', 'description': 'Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '24458.932', 'spread': '16649.166', 'groupId': 'OG000'}, {'value': '26862.895', 'spread': '21419.555', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciPctValue': '90', 'paramValue': '97.3', 'ciLowerLimit': '82.8', 'ciUpperLimit': '114', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on AUC0-inf', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AUC0-inf was not able to be estimated for all completing subjects', 'anticipatedPostingDate': '2009-06'}, {'type': 'PRIMARY', 'title': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period'}, {'id': 'OG001', 'title': 'Rowasa®', 'description': 'Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '21543.597', 'spread': '15674.400', 'groupId': 'OG000'}, {'value': '22911.830', 'spread': '15380.728', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciPctValue': '90', 'paramValue': '94.0', 'ciLowerLimit': '83.0', 'ciUpperLimit': '107', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on AUC0-t', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}, {'type': 'SECONDARY', 'title': 'Cmax - Maximum Observed Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period'}, {'id': 'OG001', 'title': 'Rowasa®', 'description': 'Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '2274.652', 'spread': '934.469', 'groupId': 'OG000'}, {'value': '2284.884', 'spread': '857.980', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciPctValue': '90', 'paramValue': '98.3', 'ciLowerLimit': '91.5', 'ciUpperLimit': '106', 'estimateComment': 'Metabolite results presented for informational purposes only.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Cmax results for N-Acetylmesalamine metabolite', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}, {'type': 'SECONDARY', 'title': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period'}, {'id': 'OG001', 'title': 'Rowasa®', 'description': 'Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '46564.373', 'spread': '29109.234', 'groupId': 'OG000'}, {'value': '49692.278', 'spread': '32182.649', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciPctValue': '90', 'paramValue': '97.6', 'ciLowerLimit': '86.7', 'ciUpperLimit': '110', 'estimateComment': 'Metabolite results presented for informational purposes only.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'AUC0-inf results for N-Acetylmesalamine metabolite', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AUC0-inf was not able to be estimated for all completing subjects', 'anticipatedPostingDate': '2009-06'}, {'type': 'SECONDARY', 'title': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period'}, {'id': 'OG001', 'title': 'Rowasa®', 'description': 'Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '40873.915', 'spread': '25272.348', 'groupId': 'OG000'}, {'value': '42644.677', 'spread': '24335.847', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciPctValue': '90', 'paramValue': '95.6', 'ciLowerLimit': '86.1', 'ciUpperLimit': '106', 'estimateComment': 'Metabolite results presented for informational purposes only.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'AUC0-t results for N-Acetylmesalamine metabolite', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mesalamine (Test) First', 'description': 'Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period'}, {'id': 'FG001', 'title': 'Rowasa® (Reference) First', 'description': 'Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mesalamine (Test) First', 'description': 'Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period'}, {'id': 'BG001', 'title': 'Rowasa® (Reference) First', 'description': 'Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period'}, {'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': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Biracial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', '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': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2009-02-06', 'resultsFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-02-06', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-06-30', 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Concentration', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on Cmax'}, {'measure': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on AUC0-inf'}, {'measure': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on AUC0-t'}], 'secondaryOutcomes': [{'measure': 'Cmax - Maximum Observed Concentration', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Cmax results for N-Acetylmesalamine metabolite'}, {'measure': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'AUC0-inf results for N-Acetylmesalamine metabolite'}, {'measure': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'AUC0-t results for N-Acetylmesalamine metabolite'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.', 'detailedDescription': 'Criteria for Evaluation: FDA Bioequivalence Criteria\n\nStatistical Methods: FDA bioequivalence statistical methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 18 years or older, with a body mass index (BMI) of 30 or less.\n* Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.\n* Signed informed consent form, which meets all criteria of current FDA regulations.\n* If female and of child bearing potential prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g. condom, IUD, hormonal contraceptives).\n\nExclusion Criteria:\n\n* If female pregnant, lactating, or likely to become pregnant during the study.\n* History of allergy or sensitivity to mesalamine or other salicylic drugs (e.g. aspirin, sulfasalazine) or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.\n* Colitis, hemorrhoids, anal fissures, or other disease of the anus, rectum or colon.\n* Significant history or current evidence of chronic infections disease, system disorder or organ disorder.\n* History of psychiatric disorders occuring within the last two years that required hospitalization or medication.\n* Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives).\n* Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.\n* Receipt of any drug as part of a research study within 30 days prior to dosing.\n* Drug or alcohol addiction requiring treatment in the past 12 months.\n* Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing.\n* Positive test for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.\n* Positive test results for drugs of abuse at screening.\n* Positive serum pregnancy test at screening.\n* Unable or unwilling to tolerate multiple venipunctures.'}, 'identificationModule': {'nctId': 'NCT00840203', 'briefTitle': 'Mesalamine 4 gm/60 mL Rectal Enema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 mL Rectal Enema Formulations', 'orgStudyIdInfo': {'id': '10336014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesalamine', 'description': 'Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period', 'interventionNames': ['Drug: Mesalamine 4 gm/60 mL Rectal Enema']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rowasa®', 'description': 'Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period', 'interventionNames': ['Drug: Rowasa® 4 gm/60 mL Rectal Enema']}], 'interventions': [{'name': 'Rowasa® 4 gm/60 mL Rectal Enema', 'type': 'DRUG', 'description': '1 x 4 gm/60 mL, single-dose', 'armGroupLabels': ['Rowasa®']}, {'name': 'Mesalamine 4 gm/60 mL Rectal Enema', 'type': 'DRUG', 'description': '1 x 4 gm/60 mL, single-dose', 'armGroupLabels': ['Mesalamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novum Pharmaceutical Research Services', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Shirley Ann Kennedy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novum Pharmaceutical Research Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}}}}