Viewing Study NCT01384292

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 3:29 PM

Ignite Modification Date: 2025-12-27 @ 6:36 AM

Study NCT ID: NCT01384292

Status: TERMINATED

Last Update Posted: 2015-06-01

First Post: 2011-06-28

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589308', 'term': 'naloxegol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to recruitment challenges, enrollment was stopped early. 14 patients were randomized (\\<5% of planned number), thus, there was insufficient data to perform the protocol-specified statistical analyses. Secondary outcome measures are not reported.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NKTR-118 12.5 mg - Part A', 'description': 'Part A NKTR-118 12.5 mg, oral treatment', 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NKTR-118 25 mg - Part A', 'description': 'Part A NKTR-118 25 mg, oral treatment', 'otherNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo - Part A', 'description': 'Part A Placebo, oral treatment', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'NKTR-118 12.5 mg - Part B', 'description': 'Part B NKTR-118 12.5 mg, oral treatment', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'NKTR-118 25 mg - Part B', 'description': 'Part B NKTR-118 25 mg, oral treatment', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response (Responder/Non-responder) to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-118 12.5 mg', 'description': 'NKTR-118 12.5 mg, oral treatment'}, {'id': 'OG001', 'title': 'NKTR-118 25 mg', 'description': 'NKTR-118 25 mg, oral treatment'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo, oral treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 4', 'description': 'Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NKTR-118 12.5 mg', 'description': 'NKTR-118 12.5 mg, oral treatment'}, {'id': 'FG001', 'title': 'NKTR-118 25 mg', 'description': 'NKTR-118 25 mg, oral treatment'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo, oral treatment'}], 'periods': [{'title': 'Part A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This multicenter study was conducted in Poland, the Czech Republic, and the United States between 29 June 2011 and 20 September 2012. Due to recruitment challenges, enrollment to this study was stopped early and no new patients had been screened as of 20 April 2012. Fourteen patients were randomized across the 3 treatment groups.', 'preAssignmentDetails': 'Part A was 8 weeks: 14-day screening period, 2-week OIC confirmation period, 4-week treatment period. Part B was 14 weeks: 12-week treatment period, 2-week follow-up period. Part B was optional for eligible patients completing Part A. NKTR-118 patients from Part A remained on the same NKTR-118 dose, while placebo patients received NKTR-118 25 mg.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'NKTR-118 12.5 mg', 'description': 'NKTR-118 12.5 mg, oral treatment'}, {'id': 'BG001', 'title': 'NKTR-118 25 mg', 'description': 'NKTR-118 25 mg, oral treatment'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo, oral treatment'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'spread': '9.20', 'groupId': 'BG000'}, {'value': '53.8', 'spread': '11.69', 'groupId': 'BG001'}, {'value': '52.5', 'spread': '4.93', 'groupId': 'BG002'}, {'value': '54.1', 'spread': '8.70', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'The study was stopped early due to recruitment challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2011-06-28', 'resultsFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2011-06-28', 'lastUpdatePostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-28', 'studyFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response (Responder/Non-responder) to Study Drug', 'timeFrame': 'Baseline to Week 4', 'description': 'Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.'}]}, 'conditionsModule': {'keywords': ['Cancer-Related Pain', 'Opioid-Induced Constipation', 'OIC'], 'conditions': ['Opioid-Induced Constipation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1388&filename=Clinical_Study_Report_Synopsis_D3820C00006.pdf', 'label': 'Clinical\\_Study\\_Report\\_Synopsis\\_D3820C00006'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).\n\nThe study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent prior to any study-specific procedures.\n* Men and women aged 18 or older.\n* Histologically or cytologically confirmed neoplasm causing pain and requiring management with opioids.\n* Self-reported active symptoms of OIC at screening (\\<3 RFBMs/week and experiencing \\>1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (\\<3 RFBMs/week on average aver the 2-week OIC confirmation period.\n* Receiving a stable maintenance opioid regimen consisting of a total daily dose of \\>30 mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a minimum of 4 weeks prior to screening for cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.\n\nExclusion Criteria:\n\n* Patients receiving Opioid regimen for treatment of pain other than related to cancer.\n* Any condition that may have affected the permeability of the blood-brain barrier, eg, known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy.\n* Patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are excluded. Patients with multiple myeloma will be allowed.\n* Patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior to Visit 1 (screening) and/or during Part A of the study are excluded. Any patients with suspected clinically relevant radiation-induced injury of small or large intestine are excluded.\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT01384292', 'briefTitle': 'Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients With Cancer-Related Pain', 'orgStudyIdInfo': {'id': 'D3820C00006'}, 'secondaryIdInfos': [{'id': '2011-001985-16'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 (part A and B)', 'description': 'Oral treatment', 'interventionNames': ['Drug: NKTR-118']}, {'type': 'EXPERIMENTAL', 'label': '2 (part A and B)', 'description': 'Oral treatment', 'interventionNames': ['Drug: NKTR-118']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3 (part A only)', 'description': 'Oral treatment', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NKTR-118', 'type': 'DRUG', 'description': '12.5 mg oral tablet once daily', 'armGroupLabels': ['1 (part A and B)']}, {'name': 'NKTR-118', 'type': 'DRUG', 'description': '25 mg oral tablet once daily', 'armGroupLabels': ['2 (part A and B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral treatment', 'armGroupLabels': ['3 (part A only)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Casa Grande', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.8795, 'lon': -111.75735}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'city': 'Gilroy', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.00578, 'lon': -121.56828}}, {'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Baypines', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site'}, {'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'city': 'Tavares', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.80416, 'lon': -81.72563}}, {'city': 'Albany', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Riverdale', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.57261, 'lon': -84.41326}}, {'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Anderson', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.10532, 'lon': -85.68025}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.21261, 'lon': -76.71358}}, {'city': 'Hollywood', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.07511, 'lon': -76.5858}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Fairhaven', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.6376, 'lon': -70.90365}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'city': 'Southaven', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98898, 'lon': -90.01259}}, {'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Flat Rock', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.27123, 'lon': -82.44151}}, {'city': 'Morrisville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}, {'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Beavercreek', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.70923, 'lon': -84.06327}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Middleton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.84339, 'lon': -80.65118}}, {'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Sugarland', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site'}, {'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Broadmeadow', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -32.92371, 'lon': 151.72849}}, {'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'city': 'Malvern', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.86259, 'lon': 145.02811}}, {'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'city': 'Edegem', 'state': 'Belgium', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Mons', 'state': 'Belgium', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Wetteren', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.00526, 'lon': 3.88341}}, {'city': 'Haskovo', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 41.93415, 'lon': 25.55557}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'city': 'Shumen', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.27064, 'lon': 26.92286}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Benešov', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.78162, 'lon': 14.68697}}, {'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Wiesbaden', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Offenbach', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}, {'city': 'Brzozów', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 49.69501, 'lon': 22.01926}}, {'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Gliwice', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.29761, 'lon': 18.67658}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Research Site', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'city': 'Craiova', 'state': 'Dolj', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Ploieşti', 'state': 'Prahova', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'city': 'Baia Mare', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Brăila', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.27152, 'lon': 27.97429}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Onești', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.48134, 'lon': 27.12141}}, {'city': 'Bardejov', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.29175, 'lon': 21.27271}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Košice', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'city': 'Prešov', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'city': 'Port Elizabeth', 'state': 'Eastern Cape', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'Benoni', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Vereeniging', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -26.67313, 'lon': 27.92615}}, {'city': 'Durban', 'state': 'Kz-natal', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Goodwood', 'state': 'W Cape', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -26.4533, 'lon': 24.25963}}, {'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'A Coruña', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Penarth', 'state': 'CRF', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.4386, 'lon': -3.17342}}, {'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'city': 'Chippenham', 'state': 'Wilts', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.46, 'lon': -2.12472}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}