Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-05-04 @ 6:19 AM
Study NCT ID:
NCT01674634
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2012-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}, {'id': 'D003286', 'term': 'Contracture'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003012', 'term': 'Microbial Collagenase'}, {'id': 'C570746', 'term': 'xiapex'}], 'ancestors': [{'id': 'D017364', 'term': 'Collagenases'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalsite.inquiries@endo.com', 'title': 'Clinical Trial Coordinator', 'organization': 'Endo Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand', 'otherNumAtRisk': 715, 'otherNumAffected': 680, 'seriousNumAtRisk': 715, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 626, 'numAffected': 552}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 513, 'numAffected': 420}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 431, 'numAffected': 361}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 192, 'numAffected': 184}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 121, 'numAffected': 107}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 109, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 102, 'numAffected': 92}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Blood blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 98, 'numAffected': 89}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 61, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Axillary pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 53, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'injection site haemorrhage', 'notes': 'injection site ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 45, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 39, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Feeding tube complication', 'notes': 'PEG feeding tube obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Post procedural haemorrhage', 'notes': 'Bleeding left hand post procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lymphangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cellulitis', 'notes': 'Left lower leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Tendon rupture', 'notes': 'Upgraded to an SAE by the sponsor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 715, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Total Fixed Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}]}, {'units': 'Treated Joint Pairs', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'classes': [{'categories': [{'measurements': [{'value': '74.41', 'spread': '24.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 31', 'description': 'Percent change from baseline in total fixed flexion = 100 \\* (baseline total FFC - day 31 total FFC)/baseline total FFC, where total fixed flexion is defined as the sum of the fixed flexion contracture (FCC) of the 2 joints receiving treatment. Positive percent change from baseline indicates improvement.', 'unitOfMeasure': 'percentage of contracture change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated Joint Pairs', 'denomUnitsSelected': 'Treated Joint Pairs', 'populationDescription': 'Efficacy analysis was based on the modified intent-to-treat (mITT) population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on contralateral hand. Assessment is based on simultaneously treated joint pairs.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Total Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}]}, {'units': 'treated joint pairs', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'groupId': 'OG000', 'lowerLimit': '64.3', 'upperLimit': '68.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 31', 'description': 'The total range of motion (ROM) is the sum of the range of motion measurements of the 2 treated joints. ROM is defined as difference between full flexion angle and full extension expressed in degrees. A positive change from baseline indicates increased (improved) ROM.', 'unitOfMeasure': 'degrees', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'treated joint pairs', 'denomUnitsSelected': 'treated joint pairs', 'populationDescription': 'Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '714', 'groupId': 'OG001'}]}, {'units': 'Treated Joints', 'counts': [{'value': '896', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX MP Joint', 'description': 'AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the metacarpophalangeal (MP) joint cord'}, {'id': 'OG001', 'title': 'XIAFLEX/XIAPEX PIP Joint', 'description': 'AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the proximal interphalangeal (PIP) joint cord'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '317', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '579', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days', 'description': 'Clinical success is defined as reduction of FFC of a treated joint to within 0-5 degrees of normal within 30 days of injection', 'unitOfMeasure': 'Joints', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated Joints', 'denomUnitsSelected': 'Treated Joints', 'populationDescription': 'Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '714', 'groupId': 'OG001'}]}, {'units': 'Treated Joints', 'counts': [{'value': '896', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX MP Joint', 'description': 'AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the MP joint cord'}, {'id': 'OG001', 'title': 'XIAFLEX/XIAPEX PIP Joint', 'description': 'AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the PIP joint cord'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '800', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days', 'description': 'Clinical improvement is defined as a reduction of FFC by 50% or greater of the baseline value within 30 days of injection', 'unitOfMeasure': 'Joints', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated Joints', 'denomUnitsSelected': 'Treated Joints', 'populationDescription': 'Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.'}, {'type': 'SECONDARY', 'title': 'Subject Assessment of Satisfaction With Treatment at Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}]}, {'units': 'Treated Joint Pairs', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '461', 'groupId': 'OG000'}]}]}, {'title': 'Quite satisfied', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Quite dissatisfied', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Not done', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 31', 'description': "Subject's were asked to rate satisfaction with treatment at the day 31 follow-up visit", 'unitOfMeasure': 'Joint Pairs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated Joint Pairs', 'denomUnitsSelected': 'Treated Joint Pairs', 'populationDescription': 'Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.'}, {'type': 'SECONDARY', 'title': 'Subject Assessment of Satisfaction With Treatment at Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}]}, {'units': 'Treated Joint Pairs', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '496', 'groupId': 'OG000'}]}]}, {'title': 'Quite satisfied', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Quite dissatisfied', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Not done', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 61', 'description': "Subject's were asked to rate satisfaction with treatment at the day 61 follow-up visit", 'unitOfMeasure': 'Joint Pairs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated Joint Pairs', 'denomUnitsSelected': 'Treated Joint Pairs', 'populationDescription': 'Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.'}, {'type': 'SECONDARY', 'title': 'Investigator Assessment of Improvement With Treatment at Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}]}, {'units': 'Treated Joint Pairs', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not done', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 31', 'description': "Investigator's determined the degree of improvement in the severity of the subject's treated finger(s) compared with screening at the day 31 follow-up visit.", 'unitOfMeasure': 'Joint Pairs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated Joint Pairs', 'denomUnitsSelected': 'Treated Joint Pairs', 'populationDescription': 'Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.'}, {'type': 'SECONDARY', 'title': 'Investigator Assessment of Improvement With Treatment at Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}]}, {'units': 'Treated Joint Pairs', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '382', 'groupId': 'OG000'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not done', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 61', 'description': "Investigator's determined the degree of improvement in the severity of the subject's treated finger(s) compared with screening at the day 61 follow-up visit.", 'unitOfMeasure': 'Joint Pairs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated Joint Pairs', 'denomUnitsSelected': 'Treated Joint Pairs', 'populationDescription': 'Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}]}, {'units': 'Treated Joint Pairs', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.3', 'spread': '9.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 31', 'description': "The Unité Rhumatologique des Affections de la Main (URAM) scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated Joint Pairs', 'denomUnitsSelected': 'Treated Joint Pairs', 'populationDescription': 'Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}]}, {'units': 'Treated Joint Pairs', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.3', 'spread': '9.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 61', 'description': "The URAM scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated Joint Pairs', 'denomUnitsSelected': 'Treated Joint Pairs', 'populationDescription': 'Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '715'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '709'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'XIAFLEX/XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '348', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '367', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '9.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '616', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '278', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 715}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2012-08-27', 'resultsFirstSubmitDate': '2015-02-04', 'studyFirstSubmitQcDate': '2012-08-28', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-02-04', 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Total Fixed Flexion', 'timeFrame': 'Baseline, Day 31', 'description': 'Percent change from baseline in total fixed flexion = 100 \\* (baseline total FFC - day 31 total FFC)/baseline total FFC, where total fixed flexion is defined as the sum of the fixed flexion contracture (FCC) of the 2 joints receiving treatment. Positive percent change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Total Range of Motion', 'timeFrame': 'Baseline, Day 31', 'description': 'The total range of motion (ROM) is the sum of the range of motion measurements of the 2 treated joints. ROM is defined as difference between full flexion angle and full extension expressed in degrees. A positive change from baseline indicates increased (improved) ROM.'}], 'secondaryOutcomes': [{'measure': 'Clinical Success', 'timeFrame': 'Within 30 days', 'description': 'Clinical success is defined as reduction of FFC of a treated joint to within 0-5 degrees of normal within 30 days of injection'}, {'measure': 'Clinical Improvement', 'timeFrame': 'Within 30 days', 'description': 'Clinical improvement is defined as a reduction of FFC by 50% or greater of the baseline value within 30 days of injection'}, {'measure': 'Subject Assessment of Satisfaction With Treatment at Day 31', 'timeFrame': 'Day 31', 'description': "Subject's were asked to rate satisfaction with treatment at the day 31 follow-up visit"}, {'measure': 'Subject Assessment of Satisfaction With Treatment at Day 61', 'timeFrame': 'Day 61', 'description': "Subject's were asked to rate satisfaction with treatment at the day 61 follow-up visit"}, {'measure': 'Investigator Assessment of Improvement With Treatment at Day 31', 'timeFrame': 'Day 31', 'description': "Investigator's determined the degree of improvement in the severity of the subject's treated finger(s) compared with screening at the day 31 follow-up visit."}, {'measure': 'Investigator Assessment of Improvement With Treatment at Day 61', 'timeFrame': 'Day 61', 'description': "Investigator's determined the degree of improvement in the severity of the subject's treated finger(s) compared with screening at the day 61 follow-up visit."}, {'measure': 'Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31', 'timeFrame': 'Baseline, Day 31', 'description': "The Unité Rhumatologique des Affections de la Main (URAM) scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function."}, {'measure': 'Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61', 'timeFrame': 'Baseline, Day 61', 'description': "The URAM scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['XIAFLEX', 'XIAPEX', "Dupuytren's disease", 'contracture'], 'conditions': ["Dupuytren's Contracture"]}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to assess the safety of two concurrent injections of AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of occurrence of targeted serious adverse events (tendon rupture/ligament injury and anaphylaxis) to historical rates of the same in clinical studies and post-marketing commercial use.\n\nThe secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.", 'detailedDescription': 'Methodology/Study Design: After all pre-injection procedures are completed on Day 1, eligible men and women will receive two concurrent injections AA4500 (AA4500/AA4500) into cord(s) affecting MP and/or PIP joints on the same or different fingers in the selected hand. A finger extension procedure to facilitate cord disruption will be performed (after administration of local anesthesia, if needed) 24 to 72 hours after injection in those subjects who do not have spontaneous disruption of their cord(s).\n\nFollow up visits for the evaluation of safety and efficacy will be required for all subjects 24 to 72 hours after injection, and on Days 15, 31, and 61.\n\nUpon completion of the day 61 follow-up visit (end of study visit), subjects who require additional treatment in the treated hand may receive up to three additional injections of AA4500 according to the XIAFLEX package insert. Subjects may receive up to a total of five injections and individual cords may receive up to a total of three injections. Subjects who require additional treatment will be followed for safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide a signed and dated informed consent\n2. Be a man or woman ≥ 18 years of age\n3. Have a diagnosis of Dupuytren\'s disease and have at least 2 fixed-flexion contractures on the same hand that are ≥ 20º in PIP and/or MP joints in fingers, other than the thumbs, which are caused by palpable cord(s) suitable for treatment\n4. Have a positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top\n5. Have a negative urine pregnancy test at screening and before injection of study drug and be using a highly effective (ie, \\< 1% failure rate) contraception method as judged by the investigator (eg, abstinence, intrauterine device \\[IUD\\], hormonal \\[estrogen/progestin\\] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study or be surgically sterile (if female of childbearing potential); or be a postmenopausal female (no menses for at least 1 year or hysterectomy).\n6. Be able to comply with the study visit schedule as specified in the protocol\n\nExclusion Criteria:\n\nA subject will be excluded from study participation if he/she:\n\n1. Received surgery (fasciectomy or surgical fasciotomy) and/or needle aponeurotomy/fasciotomy on the selected joints to be treated within 6 months before administration of study drug\n2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands\n3. Has a known systemic allergy to collagenase or any other excipient of AA4500\n4. Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX®/XIAPEX®) within 30 days before injection of study drug in the hand selected for treatment\n5. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for ≤ 150 mg aspirin daily) within 7 days before injection of study drug\n6. Has a known recent history of stroke, bleeding, or other medical condition, which in the investigator\'s opinion would make the subject unsuitable for enrollment in the study\n7. Received an investigational drug within 30 days before injection of study drug\n8. Is pregnant or intends on becoming pregnant during the study or is breastfeeding a child\n9. Has any clinically significant medical history or condition(s), including conditions that affect the hands, that would, in the opinion of the investigator, substantially increase the risk associated with the subject\'s participation in the protocol or compromise the scientific objectives of the study\n10. Has jewelry on the hand to be treated that cannot be removed'}, 'identificationModule': {'nctId': 'NCT01674634', 'briefTitle': "Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures", 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': "A Phase 3b Open-label, Historically-controlled Study to Assess the Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures With Palpable Cords", 'orgStudyIdInfo': {'id': 'AUX-CC-867'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XIAFLEX / XIAPEX', 'description': 'AA4500 (collagenase clostridium histolyticum)', 'interventionNames': ['Biological: XIAFLEX / XIAPEX']}], 'interventions': [{'name': 'XIAFLEX / XIAPEX', 'type': 'BIOLOGICAL', 'otherNames': ['AA4500 (collagenase clostridium histolyticum)'], 'description': 'injection (0.58 mg after reconstitution with sterile diluent \\[0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride\\])', 'armGroupLabels': ['XIAFLEX / XIAPEX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Orthopaedic Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'CORE Orthopaedic Medical Center', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Torrey Pines Medical Group', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92563', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Brigid Freyne, MD, Inc.', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Hand and Upper Extremity Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Orthopedic Associates', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Indiana Hand to Shoulder Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Christine M. Kleinert Institute for Hand and Microsurgery, Inc.', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '42503', 'city': 'Somerset', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Lake Cumberland Rheumatology', 'geoPoint': {'lat': 37.09202, 'lon': -84.60411}}, {'zip': '55431', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'TRIA Orthopedic Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Missoula Bone and Joint', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Orthopedic and Spine Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07724', 'city': 'Eatontown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Central Jersey Hand Surgery', 'geoPoint': {'lat': 40.29622, 'lon': -74.05097}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11733', 'city': 'Setauket', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Stony Brook', 'geoPoint': {'lat': 40.9351, 'lon': -73.11844}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC School of Medicine', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina Research Institute, Inc.', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '73109', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Health Research Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Center for Neurosurgical and Orthopedic Care and Research', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hand Microsurgery & Reconstructive Orthopaedics', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '37043', 'city': 'Clarksville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alpha Clinical Research, LLC', 'geoPoint': {'lat': 36.52977, 'lon': -87.35945}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Accurate Clinical Research, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22205', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Arthritis Clinic of Northern Virginia, PA', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}], 'overallOfficials': [{'name': 'Veronica Urdaneta, MD, MPPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}