Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT01117051
Status:
TERMINATED
Last Update Posted:
2021-06-11
First Post:
2010-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}], 'ancestors': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406662', 'term': 'prucalopride'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the early termination of the study, results should be interpreted with caution.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'once daily before breakfast for up to 12 weeks', 'otherNumAtRisk': 83, 'otherNumAffected': 30, 'seriousNumAtRisk': 83, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Prucalopride', 'description': '1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks', 'otherNumAtRisk': 86, 'otherNumAffected': 30, 'seriousNumAtRisk': 86, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'once daily before breakfast for up to 12 weeks'}, {'id': 'OG001', 'title': 'Prucalopride', 'description': '1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.305', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population includes all subjects who were randomized into the study and who had received at least 1 dose of investigational medication.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Prucalopride at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prucalopride', 'description': '1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks'}], 'classes': [{'title': 'pre-dose', 'categories': [{'measurements': [{'value': '2.827', 'spread': '1.5989', 'groupId': 'OG000'}]}]}, {'title': '5 hours post-dose', 'categories': [{'measurements': [{'value': '6.107', 'spread': '2.8839', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Prucalopride at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prucalopride', 'description': '1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks'}], 'classes': [{'title': 'pre-dose', 'categories': [{'measurements': [{'value': '3.179', 'spread': '1.9066', 'groupId': 'OG000'}]}]}, {'title': '5 hours post-dose', 'categories': [{'measurements': [{'value': '6.615', 'spread': '2.5758', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'placebo once daily before breakfast for up to 12 weeks'}, {'id': 'FG001', 'title': 'Prucalopride', 'description': '1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not meet in-/exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Sponsor's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Surgical procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomized by mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Convenience issue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'placebo once daily before breakfast for up to 12 weeks'}, {'id': 'BG001', 'title': 'Prucalopride', 'description': '1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'spread': '11.67', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '12.15', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '11.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between >=18 and <65 years', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'Between >=65 and <75 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': '>=75 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All randomized subjects (n = 174)', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population was used which includes all subjects who were randomized into the study and who had received at least 1 dose of investigational product. 174 subjects were randomized but 5 were not treated (n = 169).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'whyStopped': 'The study was stopped by the sponsor based on a non-safety related business priority decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2012-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-19', 'studyFirstSubmitDate': '2010-04-29', 'resultsFirstSubmitDate': '2013-04-02', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-17', 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week', 'timeFrame': '12 weeks', 'description': 'A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration of Prucalopride at Week 2', 'timeFrame': 'Week 2'}, {'measure': 'Plasma Concentration of Prucalopride at Week 8', 'timeFrame': 'Week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid induced constipation/prucalopride chronic non-cancer pain', 'Subjects with chronic non-cancer pain suffering from OIC'], 'conditions': ['Non-cancer Pain', 'Opioid Induced Constipation']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria to be assessed at screening:\n\n1. Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.\n2. Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1.\n3. Subject is suffering from OIC (i.e. secondary to chronic opioid use).\n4. Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.\n\nMain exclusion criteria to be assessed at screening:\n\n1. Constipation is thought to be drug-induced (except for opioids)\n2. Disallowed medication is being used\n3. Subject was on chronic therapy for chronic constipation prior to start of opioid therapy\n4. Subject is suffering from secondary causes of chronic constipation.'}, 'identificationModule': {'nctId': 'NCT01117051', 'acronym': 'OIC', 'briefTitle': 'Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride in Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation', 'orgStudyIdInfo': {'id': 'M0001-C301'}, 'secondaryIdInfos': [{'id': 'SPD555-301', 'type': 'OTHER', 'domain': 'Shire Development LLC'}, {'id': '2009-015652-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Resolor', 'description': 'prucalopride', 'interventionNames': ['Drug: prucalopride']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}, {'name': 'prucalopride', 'type': 'DRUG', 'description': '1 or 2 mg prucalopride once daily before breakfast', 'armGroupLabels': ['Resolor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}